Label: SEBOBALANCE SPOT CONTROL- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62499-384-07, 62499-384-11 - Packager: Laboratoire Dr. Renaud
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated June 30, 2010
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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
- KEEP OUT OF REACH OF CHILDREN
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INGREDIENTS AND APPEARANCE
SEBOBALANCE SPOT CONTROL
salicylic acid gelProduct 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)