P-Care K80G

Intramuscular

Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows:

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.

Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.

Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

Neoplastic diseases: For the palliative management of leukemias and lymphomas.

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.

Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.

Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Intra-Articular

The intra-articular or soft tissue administration of Kenalog-40 Injection is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis, or osteoarthritis.

Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.

Gebauer's Pain Ease Medium Stream Spray and Mist Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Pain Ease instantly controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

Press the actuator button firmly, allowing Pain Ease to spray from the can.

PRE-INJECTION & MINOR SURGICAL TOPICAL ANESTHESIA:
Have all necessary equipment ready and prepare the procedure site per facility's protocol. Hold the can upright, 3 to 7 inches (8 to 18 cm) from the procedure site, about a can's length away. Spray steadily 4 to 10 seconds or until the skin begins turning white, whichever comes first. Do not spray longer than 10 seconds. After spraying the site, immediately perform the procedure. The anesthetic effect of Pain Ease lasts about one minute. Reapply if necessary.
*Apply petrolatum to protect the adjacent area for minor surgical procedures.

TEMPORARY RELIEF OF MINOR SPORTS INJURIES

The pain of bruises, contusions, swelling, minor sprains, cuts and abrasions may be controlled with Pain Ease. The amount of cooling depends on the dosage. Dosage varies with duration of application. The smallest dose needed to produce the desired effect should be used. The anesthetic effect of Pain Ease lasts about one minute. This time interval is usually sufficient to help reduce or relieve the initial trauma of the injury. Hold the can upright, 3 to 7 inches (8 to 18 cm) from the target area, about a can's length away. Spray steadily 4 to 10 seconds or until the skin begins turning white, whichever comes first. Do not spray longer than 10 seconds. Reapply if necessary.

Antiseptic

NDC 49836-009-20

RX-Only

P-Care K80G

Kit Contains:
2 Kenalog-40® Single Dose Vial (1 mL)
1 Gebauer's Pain Ease® (30 mL)
1 Sterile Povidone-Iodine Swabsticks (3 Swabs)
1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5)
1 Sterile Towel Drape
1 Sterile Fenestrated Towel Drape
2 Sterile Adhesive Bandage
2 Sterile Adhesive Spot Bandage
3 Sterile Packs of 4x4 Gauze (6 Gauzes)
5 Sterile Isopropyl Alcohol 70% Prep Pad
1 Non-Sterile Face Mask

Needles and Syringes Not Included

1 Dose

P-Care K80G

DISTRIBUTED BY:
SCHMIGS
HAUPPAUGE, NY 11788

MANUFACTURED BY:

Rx Pharma
Pack
HAUPPAUGE, NY 11788

NDC 49836-009-20

Questions/Comments 1-844-632-7898

Kit Contents:

Kenalog-40®† (Bristol-Myers Squibb)*
Triamcinolone Acetonide Injectable Suspension, USP
Each mL provides 40 mg triamcinolone acetonide, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension; sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5.

Gebauer's Pain Ease®¶ (30 mL) (Gebauer Company)
Instant Topical Anesthetic Medium Stream Spray

Sterile Povidone-Iodine Swabsticks (Aplicare)*

Sterile Nitrile Powder-Free Gloves (Dynarex) - Size 7.5*

Sterile Towel Drape (Dynarex)*

Sterile Fenestrated Towel Drape (Dynarex)*

Sterile Adhesive Bandage (Dynarex)*

Sterile Adhesive Spot Bandage (Dynarex)*

Sterile 4x4 Gauze (Dynarex)*

Sterile Alcohol Prep Pad 70% by Volume (Dynarex)*

Face Mask with Ear Loops (Dynarex)

† Kenalog-40® (registered trademark of Bristol-Myers Squibb)
¶ Gebauer's Pain Ease® (registered trademark of Gebauer Company)
* Internal package components remain sterile when stated as long as items are unopened and undamaged.

WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

PROTECT FROM LIGHT/AVOID FREEZING

STORE AT CONTROLLED ROOM TEMPERATURE 20º-25ºC (68º-77ºF) [SEE USP CONTROLLED ROOM TEMPERATURE]

DO NOT REFRIGERATE

Directions for Use: See enclosed inserts.

SUSTAINABLE
FORESTRY
INITIATIVE
Certified Sourcing
www.sfiprogram.org
SFI-01376

ORG 04/2017

This product is not eligible for Medicare or Medicaid reimbursement.

P-Care K80G

NDC 0003-0293-05

KENALOG®-40
(Triamcinolone
Acetonide Injectable
Suspension, USP)

40 mg per 1 mL

Rx only

Read all side

Bristol-Myers Squibb

Each mL provides 40 mg
triamcinolone acetonide with
0.65% sodium chloride for
isotonicity, 0.99% (w/v) benzyl
alcohol  added as a preservative,
0.75% carboxymethylcellulose
sodium, and 0.04% polysorbate
80 in an aqueous suspension;
sodium hydroxide or hydrochloric
acid may be present to adjust
pH to 5.0-7.5.

Shake well before using.

For Intramuscular or
intra-articular use only.

NOT FOR IV, ID, INTRAOCULAR,
EPIDURAL, OR INTRATHECAL
USE.

See insert for dosage
information.

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
Product of Spain     1132705A5

Store at controlled room
temperature, 20º -25ºC
(68º-77ºF), avoid freezing and
protect from light.

Do not refrigerate.

Store vial in carton.

See bottom panel for lot number
and expiration date.

Kenalog-40

NDC 52380-3101-5

NPN 02076101

APLICARE®

Tear Here               Hold Upright               Tear Here

THREE
POVIDONE-IODINE
SWABSTICKS

ANTISEPTIC
STERILE Solution
Applicator is STERILE if Package
is Intact

Three 4-inch Saturated Swabsticks

STERILE SOLUTION

Reorder No. S-3101

For questions, comments, or to report
serious side effects:
800-760-3236
Monday-Friday 8:30 a.m.-5:00 p.m. EST
APLICARE, INC.
MERIDEN, CT 06450 U.S.A.
BRAMPTON, ON L6W 4V3 CANADA
www.aplicare.com
0915

Povidone-Iodine

Redness or pain at the injection site, stomach upset, headache, dizziness, menstrual period changes, trouble sleeping, or weight gain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: bone pain, easy bruising/bleeding, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, increased thirst/urination, fast/pounding/irregular heartbeat, shortness of breath, swelling of the ankles/feet, persistent weight gain, puffy face, unusual hair growth, thinning skin, slow wound healing, signs of infection (e.g., persistent fever/cough/sore throat, painful urination, eye pain/discharge), muscle weakness/pain, mental/mood changes (e.g., mood swings, depression, agitation, confusion), vision changes, seizures, unusual skin growths.

If you have received injection of this medication into the joint, temporary discomfort of the joint may occur. Tell your doctor right away if you have fever, increased/severe pain with swelling of the joint, weakness in the joint, or decreased range of motion in the joint.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.