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.

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DRUG FACTS

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

OILY SK SPECIFIC SOLUTIONS 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.06 mL  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
MALIC ACID (UNII: 817L1N4CKP)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
ALMOND (UNII: 3Z252A2K9G)  
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
MAHONIA AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75870-007-021 in 1 CARTON
1NDC:75870-007-0115 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/15/2008
Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE (467582193)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE 467582193manufacture

Revised: 6/2011
Document Id: ec831854-bda7-467b-b309-ed1519b1ea7e
Set id: 26789164-1e7c-4131-8edf-96e752c0fe4d
Version: 2
Effective Time: 20110621
 
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE