OILY SK BALANCING I - salicylic acid cream 
LABORATORIOS DE COSMETICA SCIENTIFI

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

Active Ingredient

Salicylic Acid 1%

Purpose:  Acne Treatment

Keep out of reach of children.

Uses:  Daily treatment cream for acne-prone skin.

Warnings:

Directions:  Apply a dime size amount to cleansed skin with a light massage.  Use morning and night.

Other Ingredients:  WATER, HYDROGENATED POLYDECENE, ALCOHOL DENAT., BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, DIMETHICONE, CETYL ALCOHOL, GLYCERIN, MAGNESIUM ALUMINUM SULFATE, ZINC PCA, CAPRYLOYL GLYCINE, METHYL METHACRYLATE CROSSPOLYMER, MALIC ACID, SODIUM SALICYLATE, BISABOLOL, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, PLANTAGO LANCEOLATA LEAF EXTRACT, HYPERICUM PERFORATUM EXTRACT, OLEANOLIC ACID, HYDROLYZED SWEET ALMOND PROTEIN, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, MENTHA PIPERITA (PEPPERMINT) OIL, BERBERIS AQUIFOLIUM EXTRACT, POLYSORBATE 80, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, SODIUM HYDROXIDE.

IMAGE OF CARTON

OILY SK BALANCING I 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.5 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
SULFURIC ACID (UNII: O40UQP6WCF)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
MAHONIA AQUIFOLIUM FRUITING TOP (UNII: P119855ERN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MALIC ACID (UNII: 817L1N4CKP)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
LEVOMENOL (UNII: 24WE03BX2T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
HYPERICUM PERFORATUM LEAF (UNII: DOC7OB843Y)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
ALMOND (UNII: 3Z252A2K9G)  
LEMON OIL (UNII: I9GRO824LL)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MAHONIA AQUIFOLIUM FRUITING TOP (UNII: P119855ERN)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75870-009-021 in 1 CARTON
1NDC:75870-009-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/15/2007
Labeler - LABORATORIOS DE COSMETICA SCIENTIFI (467582193)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE 467582193manufacture

Revised: 6/2011
Document Id: 3d1c0612-3dc2-40b1-ac4c-18bbebac7b07
Set id: bbd72566-c027-4ae1-8de6-8e310d9ad728
Version: 3
Effective Time: 20110617
 
LABORATORIOS DE COSMETICA SCIENTIFI