Xilapak

Name: Xilapak

Xilapak KIT DESCRIPTION

Xilapak is supplied as 3 components in a kit:

- FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% (NDC 52565-012-59), 60mL - CETAPHIL CLEANSER (NDC 00299-3921-40), 4 fl oz - SILICONE TAPE, 1 Roll, 5.5 yards

Contraindications

Do not use if known hypersensitivity to any of the listed ingredients of any of the components included in the kit.

Product details

For All Skin Types

  • Mild, non-irritating formula
  • Softens as it cleans
  • Non-comedogenic/fragrance free
  • Dermatologist recommended

This gentle, soap-free cleanser was originally formulated for dermatologists, specifically for everyday cleansing of even the most sensitive skin.

  • Soothing, non-irritating cleanser ideal for face, hands and body
  • Helps skin retain needed moisture
  • Rinses easily and leaves skin feeling soft, smooth and healthy

Ingredients: Water, Cetyl Alcohol, Propylene Glycol, Sodium Lauryl Sulfate, Stearyl Alcohol, Methylparaben, Propylparaben, Butylparaben

Cetaphil Cleanser is easy to use:

Directions for use with water: Apply cleanser and gently massage into skin. Rinse.

Directions for use without Water: Apply a liberal amount to the skin and rub gently. Remove excess with a soft cloth, leaving a thin film of CETAPHIL on the skin.

Side Effects

No common side effects have been reported with this product. Stop use and ask a doctor if rash occurs.

Silicone Tape, 1 Roll, 5.5 yards

Purpose

For alleviating tension on the scar and its surrounding skin. Tension on a wound and scar is known to increase scar tissue formation.

Because of its adherence, silicone tape reduces tension (e.g. tear and stretch) along the incision line or wound which is known to minimize the degree of scarring in terms of spreading or thickening.

PRINCIPAL DISPLAY PANEL - Kit Carton

Solutech
PHARMACEUTICALS

Xilapak KIT

NDC 70350-5218-1

RX ONLY

Established Pharmacological Class
Substance Pharmacological Class
CETAPHIL CLEANSER CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
Xilapak 
fluocinolone acetonide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70350-5218
Packaging
# Item Code Package Description
1 NDC:70350-5218-1 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, WITH APPLICATOR 60 mL
Part 2 1 BOTTLE 118 mL
Part 1 of 2
FLUOCINOLONE ACETONIDE 
fluocinolone acetonide solution
Product Information
Item Code (Source) NDC:52565-012
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE 0.1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID  
PROPYLENE GLYCOL  
Packaging
# Item Code Package Description
1 NDC:52565-012-59 1 BOTTLE, WITH APPLICATOR in 1 CARTON
1 60 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA015296 11/27/2012
Part 2 of 2
CETAPHIL   CLEANSER
rinse
Product Information
Item Code (Source) 0299-3921
Route of Administration TOPICAL DEA Schedule     
Ingredients
Ingredient Name Quantity
Water  
CETYL ALCOHOL  
PROPYLENE GLYCOL  
SODIUM LAURYL SULFATE  
STEARYL ALCOHOL  
METHYLPARABEN  
PROPYLPARABEN  
BUTYLPARABEN  
Packaging
# Item Code Package Description
1 0299-3921-40 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA015296 11/01/2017
Labeler - SOLUTECH PHARMACEUTICALS LLC (080040396)
Revised: 11/2017   SOLUTECH PHARMACEUTICALS LLC
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