Oily SK Cleansing: Package Insert and Label Information

OILY SK CLEANSING — 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

Active Ingredient:

Salicylic Acid 1%

Keep out of reach of children.

Uses: For the daily cleansing of acne and oily-prone skin.

Warnings :

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

Directions : Apply Cleansing Gel to previously moistened skin with a gentle massage until a soft lather is produced. Leave for 1-2 minutes and then rinse.


COSMETIC INGREDIENTS: WATER, DISODIUM COCOAMPHODIACETATE, PEG-7 CLYCERYL COCOATE, COCAMIDOPROPYL BETAINE, PEG-200 HYDROGENATED GLYCERYL PALMATE, SODIUM CHLORIDE, ZINC PCA, MENTHYL LACTATE, CHLORHEXIDINE DIGLUCONATE, ALLANTOIN, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, MENTHA PIPERITA (PEPPERMINT) OIL, POLYSORBATE 80, PHENOXYETHANOL, 2,4-DICHLOROBENZYL ALCOHOL, PROPYLENE GLYCOL, GLYCERIN.

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OILY SK CLEANSING
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75870-008
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1.15 mL in 115 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DISODIUM COCOAMPHODIACETATE
COCAMIDOPROPYL BETAINE
POLYETHYLENE GLYCOL 200
SODIUM CHLORIDE
ZINC PIDOLATE
MENTHYL LACTATE
CHLORHEXIDINE GLUCONATE
ALLANTOIN
LEMON OIL
PEPPERMINT OIL
POLYSORBATE 80
PHENOXYETHANOL
PROPYLENE GLYCOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75870-008-02 1 BOTTLE, PUMP (BOTTLE) in 1 CARTON contains a BOTTLE, PUMP (75870-008-01)
1 NDC:75870-008-01 115 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (75870-008-02)
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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