Oily SK Balancing I: Package Insert and Label Information

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.

Active Ingredient

Salicylic Acid 1%

Purpose: Acne Treatment

Keep out of reach of children.

Uses: Daily treatment cream for acne-prone skin.

Warnings:

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

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
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OILY SK BALANCING I
salicylic acid cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75870-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID .5 mL in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROGENATED POLYDECENE (550 MW)
ALCOHOL
BUTYLENE GLYCOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
DIMETHICONE
CETYL ALCOHOL
GLYCERIN
SULFURIC ACID
ZINC PIDOLATE
MAHONIA AQUIFOLIUM FRUITING TOP
ALOE VERA LEAF
MALIC ACID
SODIUM SALICYLATE
LEVOMENOL
XANTHAN GUM
ANNICKIA CHLORANTHA BARK
PLANTAGO LANCEOLATA LEAF
HYPERICUM PERFORATUM LEAF
OLEANOLIC ACID
ALMOND
LEMON OIL
PEPPERMINT OIL
MAHONIA AQUIFOLIUM FRUITING TOP
POLYSORBATE 80
PHENOXYETHANOL
METHYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
PROPYLPARABEN
ISOBUTYLPARABEN
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75870-009-02 1 TUBE (TUBE) in 1 CARTON contains a TUBE (75870-009-01)
1 NDC:75870-009-01 50 mL in 1 TUBE This package is contained within the CARTON (75870-009-02)
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 Operations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE 467582193 manufacture

Revised: 06/2011 LABORATORIOS DE COSMETICA SCIENTIFI

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