Label: OILY SK BALANCING I- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75870-009-01, 75870-009-02 - Packager: LABORATORIOS DE COSMETICA SCIENTIFI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 17, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
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.
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INGREDIENTS AND APPEARANCE
OILY SK BALANCING I
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75870-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID .5 mL in 50 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:75870-009-02 1 in 1 CARTON 1 NDC:75870-009-01 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/15/2007 Labeler - LABORATORIOS DE COSMETICA SCIENTIFI (467582193) Establishment Name Address ID/FEI Business Operations LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE 467582193 manufacture
