Oily SK Specific Solutions: Package Insert and Label Information

OILY SK SPECIFIC SOLUTIONS — salicylic acid gel
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

PURPOSE
Acne treatment

INDICATIONS AND INSTRUCTIONS FOR USE: When blemish appears, apply directly on the affected area. Use twice a day until the disappearance of the blemish.

WARNINGS: For external use only. Avoid contact with the eyes and mucous membranes. Discontinue use if signs of irritation or rash appear.

ACTIVE INGREDIENT:

Salicylic Acid — .40% — Purpose: acne treatment

COSMETIC INGREDIENTS: WATER, ALCOHOL DENAT., GLYCERIN, HYDROXYETHYL ETHYLCELLULOSE, CAPRYLOYL GLYCINE, MALIC ACID, SODIUM SALICYLATE, CHLORHEXIDINE DIGLUCONATE, HYDROLYZED SWEET ALMOND PROTEIN, PLANTAGO LANCEOLATA LEAF EXTRACT, ZINC PCA, BERBERIS AQUIFOLIUM EXTRACT, BUTYLENE GLYCOL, SODIUM HYDROXIDE.

Keep out of reach of children.

INSTRUCTIONS FOR USE: Squeeze a small amount onto the affected area twice a day until the blemish is gone.

Oily SK Specific Solution Carton
(click image for full-size original)

OILY SK SPECIFIC SOLUTIONS
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75870-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID .06 mL in 15 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
GLYCERIN
CAPRYLOYL GLYCINE
MALIC ACID
SODIUM SALICYLATE
CHLORHEXIDINE GLUCONATE
ALMOND
PLANTAGO LANCEOLATA LEAF
ZINC PIDOLATE
MAHONIA AQUIFOLIUM ROOT BARK
BUTYLENE GLYCOL
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75870-007-02 1 TUBE (TUBE) in 1 CARTON contains a TUBE (75870-007-01)
1 NDC:75870-007-01 15 mL in 1 TUBE This package is contained within the CARTON (75870-007-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/15/2008
Labeler — LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE (467582193)
Establishment
Name Address ID/FEI Operations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE 467582193 manufacture

Revised: 06/2011 LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE

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