SEBOBALANCE PURIFYING SEBO-ABSORBING MASK- salicylic acid paste

SEBOBALANCE Purifying Sebo-absorbing Mask by

Drug Labeling and Warnings

SEBOBALANCE Purifying Sebo-absorbing Mask 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 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.

PRINCIPAL DISPLAY PANEL

image of carton 60g label

image of tube 200g label

image of tube 60g label

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KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INGREDIENTS AND APPEARANCE

SEBOBALANCE PURIFYING SEBO-ABSORBING MASK 
salicylic acid paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62499-535
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)
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
Color	blue (dark bleu)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62499-535-11	1 in 1 CARTON
1	NDC: 62499-535-08	60 g in 1 TUBE
2	NDC: 62499-535-09	200 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/29/2010

Labeler - Laboratoire Dr. Renaud (202501565)