Clenia Cream

Name: Clenia Cream

Indications

CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash and CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

How is Clenia Cream Supplied

CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash is available in 6 oz (170 g) bottles (NDC 0245-0168-06) and 12 oz (340 g) bottles (NDC 0245-0168-12).

CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream is available in 1 oz (28 g) tubes (NDC 0245-0169-01).

Store at 15-25°C (59-77°F). Avoid excessive heat.

Manufactured for
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447

by: Contract Pharmaceuticals Limited Canada
Mississauga, Ontario L5N 6L6
CANADA

US Patent 6,977,081 for CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream

100556-01
Revised 0808
2004618

PRINCIPAL DISPLAY PANEL - 5 g sample bottle label

NDC 0245-0168-20

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Foaming Wash

5 g (0.2 oz)

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 5 g sample bottle carton

NDC 0245-0168-20

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Foaming Wash

20 packets of 5 g (0.2 oz) each
PROFESSIONAL SAMPLES: Not for Sale

UPSHER-SMITH

CLENIA 
sulfacetamide sodium and sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0245-0169
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sulfacetamide sodium (sulfacetamide) sulfacetamide 100 mg  in 1 g
sulfur (sulfur) sulfur 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
allantoin  
edetate disodium  
Glyceryl Monostearate  
isopropyl myristate  
methylparaben  
polyoxyl 8 stearate  
propylene glycol  
propylparaben  
water  
sodium thiosulfate  
stearic acid  
xanthan gum  
Packaging
# Item Code Package Description
1 NDC:0245-0169-01 1 TUBE (TUBE) in 1 CARTON
1 28 g in 1 TUBE
2 NDC:0245-0169-20 1 TUBE (TUBE) in 1 CARTON
2 3 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2009
CLENIA 
sulfacetamide sodium and sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0245-0168
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sulfacetamide sodium (sulfacetamide) sulfacetamide 100 mg  in 1 g
sulfur (sulfur) sulfur 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
butylated hydroxytoluene  
edetate disodium  
Glyceryl Monostearate  
polyoxyl 100 stearate  
magnesium aluminum silicate  
methylparaben  
propylene glycol  
propylparaben  
water  
silicon dioxide  
sodium thiosulfate  
stearic acid  
titanium dioxide  
xanthan gum  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:0245-0168-06 1 BOTTLE (BOTTLE) in 1 CARTON
1 170 g in 1 BOTTLE
2 NDC:0245-0168-12 1 BOTTLE (BOTTLE) in 1 CARTON
2 340 g in 1 BOTTLE
3 NDC:0245-0168-20 20 PACKET (PACKET) in 1 CARTON
3 5 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2009
Labeler - Upsher-Smith Laboratories, Inc (047251004)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories, Inc 047251004 ANALYSIS
Establishment
Name Address ID/FEI Operations
Contract Pharmaceuticals Limited Canada 208761249 ANALYSIS, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Innopharm 201939910 ANALYSIS
Revised: 09/2009   Upsher-Smith Laboratories, Inc

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad skin irritation.
  • Very bad and rarely deadly effects have happened with sulfa (sulfonamide) drugs like this one. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dry skin.
  • Itching.
  • Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Clenia Emollient Cream may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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