SEBOBALANCE Purifying Sebo-absorbing Mask

Dosage form: paste
Ingredients: SALICYLIC ACID 1g in 100g
Labeler: Laboratoire Dr. Renaud
NDC Code: 62499-535

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 INGREDIENTSalicylic Acid 1% w/w.

INACTIVE INGREDIENTSWATER/EAU • HECTORITE • BUTYLENE GLYCOL • SORBITOL • KAOLIN • MAGNESIUM ALUMINIUM SILICATE • ZINC OXIDE • PEG-40 HYDROGENATED CASTOR OIL • LACTIC ACID • XANTHAN GUM • ALMOND (PRUNUS AMYGDALUS DULCIS) OIL • ROSEMARY (ROSMARINUS OFFICINALIS) OIL • SAGE (SALVIA OFFICINALIS) OIL SPANISH • LAVANDIN (LAVANDULA LATIFOLIA) OIL • COLEUS FORSKOHLII OIL • GALANGAL (KAEMPFERIA GALANGA) EXTRACT • CHAMOMILE (ANTHEMIS NOBILIS) OIL • PEG-60 ALMOND GLYCERIDES • CAPRYLYL GLYCOL • CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL • NORDIHYDROGUAIARETIC ACID • OLEANOLIC ACID • ALLANTOIN • GLYCERIN • PHENOXYETHANOL • ETHYLHEXYLGLYCERIN • CARBOMER •

For the treatment of acne and allows skin to heal.

DIRECTIONSOnce or twice a week, after
a thorough cleansing of the skin, apply evenly
and sparingly to the face and the neck.
Pause for 20 minutes. Rinse liberally first with
lukewarm water, then with cold.

WARNINGSFor external use only.
Using other topical acne medications at the same
time or immediately following use of this product
may increase dryness or irritation of the skin.
If this occurs, only one medication should be
used unless directed by a doctor. Avoid
direct contact with the eyes. If product gets
into the eyes, rinse liberally with water.
Discontinue use if skin irritation develops or
increases. If irritation persists, consult a doctor.




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Keep out of reach of children.
SEBOBALANCE PURIFYING SEBO-ABSORBING MASK 
salicylic acid paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-535
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HECTORITE 
BUTYLENE GLYCOL 
SORBITOL 
KAOLIN 
MAGNESIUM ALUMINUM SILICATE 
ZINC OXIDE 
HYDROGENATED CASTOR OIL 
LACTIC ACID 
XANTHAN GUM 
PHENOXYETHANOL 
ALMOND OIL 
ROSEMARY OIL 
SAGE OIL 
LAVANDIN OIL 
GALANGAL OIL 
CHAMOMILE FLOWER OIL 
CAPRYLYL GLYCOL 
ORANGE OIL 
ALLANTOIN 
GLYCERIN 
ETHYLHEXYLGLYCERIN 
CARBOMER 934 
MASOPROCOL 
OLEANOLIC ACID 
Product Characteristics
Colorblue (dark bleu) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62499-535-111 TUBE (TUBE) in 1 CARTON
1NDC:62499-535-0860 g in 1 TUBE
2NDC:62499-535-09200 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/29/2010
Labeler - Laboratoire Dr. Renaud (202501565)

Revised: 06/2010
 
Laboratoire Dr. Renaud

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.

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