Oily SK Balancing I

Dosage form: cream
Ingredients: SALICYLIC ACID .5mL in 50mL
Labeler: LABORATORIOS DE COSMETICA SCIENTIFI
NDC Code: 75870-009

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 Facts

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.


OILY SK BALANCING I 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID.5 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:75870-009-021 TUBE (TUBE) 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/FEIOperations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE 467582193manufacture

Revised: 06/2011
 
LABORATORIOS DE COSMETICA SCIENTIFI

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)