SEBOBALANCE SPOT CONTROL- salicylic acid gel

SEBOBALANCE Spot Control by

Drug Labeling and Warnings

SEBOBALANCE Spot Control by is a Otc medication manufactured, distributed, or labeled by Laboratoire Dr. Renaud. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

Image of carton label

Image of bottle label

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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INGREDIENTS AND APPEARANCE

SEBOBALANCE SPOT CONTROL  
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62499-384
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62499-384-11	1 in 1 CARTON
1	NDC: 62499-384-07	8 g in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/30/2010

Labeler - Laboratoire Dr. Renaud (202501565)

Registrant - Laboratoire Dr. Renaud (202501565)