SEBOBALANCE SPOT CONTROL  - salicylic acid gel 
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 • ALCOHOL DENAT • SORBITOL • METHYL GLUCETH 20 • GLYCOLIC ACID • GLYCERIN •
ALPHA-GLUCAN OLIGOSACCHARIDE • SODIUM CITRATE • BUTYLENE GLYCOL • PROPYLENE GLYCOL • SODIUM HYDROXIDE • AMYLOPECTIN • XANTHAN GUM • DEXTRIN • HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT • ARGININE • CELLULOSE GUM • ALLANTOIN • PEUMUS BOLDUS LEAF EXTRACT • ASCOPHYLLUM NODOSUM EXTRACT • ANTHEMIS NOBILIS FLOWER EXTRACT • CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT • CENTAUREA CYANUS FLOWER EXTRACT • TILIA VULGARIS FLOWER EXTRACT • CALENDULA OFFICINALIS FLOWER EXTRACT • HYPERICUM PERFORATUM EXTRACT • ASPARAGOPSIS ARMATA EXTRACT • ETHYLHEXYLGLYCERIN • PHENOXYETHANOL •

For the treatment of acne. Dries and clears acne pimples, blackheads and whiteheads and allows skin to heal.

DIRECTIONS

Morning and evening, after a thorough cleansing of the skin, apply SeboBalance Spot Control
Gel locally on cutanous imperfections. Then apply the usual day or night cream. Renew application 1 to 3 times daily.

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. This product contains alpha-hydroxy-acids (AHA) which may increase sensitivity to the sun and lead to skin burn. Reduce sun exposure and use a sunblock during the use of this product and the week following its use.

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image of carton label


Image of bottle label
image of bottle label

Keep out of reach of children.

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SEBOBALANCE SPOT CONTROL  
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-384
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)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
AMYLOPECTIN (UNII: 4XO4QFV777)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
ARGININE (UNII: 94ZLA3W45F)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ALLANTOIN (UNII: 344S277G0Z)  
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
CHAMOMILE (UNII: FGL3685T2X)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
ASPARAGOPSIS ARMATA (UNII: 2936KN6I1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62499-384-111 in 1 CARTON
1NDC:62499-384-078 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/30/2010
Labeler - Laboratoire Dr. Renaud (202501565)
Registrant - Laboratoire Dr. Renaud (202501565)

Revised: 6/2010
Document Id: a1bf5e85-1fd0-4050-8071-f15f3bc6042b
Set id: 8e614b35-b63a-4b0f-a0a4-3d8225ac23e2
Version: 4
Effective Time: 20100630
 
Laboratoire Dr. Renaud