OILY SK BALANCING I- salicylic acid cream

Oily SK Balancing I by

Drug Labeling and Warnings

Oily SK Balancing I by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS DE COSMETICA SCIENTIFI, LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Salicylic Acid 1%

PURPOSE

Purpose:  Acne Treatment

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Uses:  Daily treatment cream for acne-prone skin.

WARNINGS

Warnings:

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

DOSAGE & ADMINISTRATION

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OILY SK BALANCING I 
salicylic acid cream

Product 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