SEBOBALANCE PURIFYING SEBO-ABSORBING MASK - salicylic acid  paste 
Laboratoire Dr. Renaud

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.

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Drug Facts

ACTIVE INGREDIENT

Salicylic Acid 1% w/w.

INACTIVE INGREDIENTS

WATER/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.

DIRECTIONS

Once 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.

WARNINGS

For 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.




image of carton 60g label
image of carton 60g label

image of tube 200g label
image of tube 200g label

image of tube 60g label
image of tube 60g label




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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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HECTORITE (UNII: 08X4KI73EZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SORBITOL (UNII: 506T60A25R)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
LACTIC ACID (UNII: 33X04XA5AT)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALMOND OIL (UNII: 66YXD4DKO9)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SAGE OIL (UNII: U27K0H1H2O)  
LAVANDIN OIL (UNII: 9RES347CKG)  
GALANGAL OIL (UNII: K0951TAR6Z)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ORANGE OIL (UNII: AKN3KSD11B)  
ALLANTOIN (UNII: 344S277G0Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER 934 (UNII: Z135WT9208)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
Product Characteristics
Colorblue (dark bleu) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62499-535-111 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: 6/2010
Document Id: 6d00776f-043e-4e47-974d-a9f6fa630108
Set id: 21b4619d-324c-4ad5-b82b-40377e4a2f1d
Version: 3
Effective Time: 20100629
 
Laboratoire Dr. Renaud