OTC Medication Information: SEBOBALANCE Spot Control

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.

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. Image of carton label
image of carton label
(click image for full-size original)

Image of bottle label
image of bottle label
(click image for full-size original)

image of carton labelimage of bottle label Keep out of reach of children.
SEBOBALANCE SPOT CONTROL
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62499-384
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
SORBITOL
METHYL GLUCETH-20
GLYCOLIC ACID
GLYCERIN
SODIUM CITRATE
BUTYLENE GLYCOL
PROPYLENE GLYCOL
PHENOXYETHANOL
SODIUM HYDROXIDE
AMYLOPECTIN
XANTHAN GUM
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
ARGININE
CARBOXYMETHYLCELLULOSE SODIUM
ALLANTOIN
PEUMUS BOLDUS LEAF
ETHYLHEXYLGLYCERIN
ASCOPHYLLUM NODOSUM
CHAMAEMELUM NOBILE FLOWER
CHAMOMILE
CENTAUREA CYANUS FLOWER
TILIA CORDATA FLOWER
CALENDULA OFFICINALIS FLOWER
HYPERICUM PERFORATUM
ASPARAGOPSIS ARMATA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62499-384-11 1 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 CARTON contains a BOTTLE, WITH APPLICATOR (62499-384-07)
1 NDC:62499-384-07 8 g in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (62499-384-11)
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)

Revised: 06/2010 Laboratoire Dr. Renaud

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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