CLEAR UP Cleansing: Package Insert and Label Information

CLEAR UP CLEANSING — 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 2 % w/w

INACTIVE INGREDIENTS

WATER/EAU • COCAMIDOPROPYL BETAINE •
TRIETHANOLAMINE • BUTYLENE GLYCOL • DISODIUM LAURETH SULFOCCINATE •
METHYL GLUCETH-20 • GLYCERIN • COCAMIDE MEA • PEG-40 HYDROGENATED
CASTOR OIL • GLYCOLIC ACID • SODIUM COCOYL ISETHIONATE •
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER • CITRUS AURANTIUM
DULCIS (ORANGE) PEEL OIL • 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 • ALLANTOIN • PHENOXYETHANOL • XANTHAN GUM •
CARBOXYMETHYLCELLULOSE • ETHYLHEXYL GLYCERIN • TETRASODIUM EDTA

For the treatment of acne. Helps clear acne blemishes and allows skin to heal.

DIRECTIONS

Morning and evening, moisten
the skin and apply a small quantity of CLEAR UP
Cleansing Gel to the forehead, the cheeks, the chin,
the neck and décolleté and massage gently with
fi ngertips, insisting on the T zone (forehead, nose,
chin), while avoiding the eye contour.
Add a little lukewarm water and lather.
Rinse thoroughly fi rst with lukewarm water,
then with cold. Dry skin gently.
N.B.: You may also work the Cleansing Gel
into a lather with a little water in the palm
of the hand before applying.

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.

image of carton 200ml label

image of carton 200ml label
(click image for full-size original)
image of tube 60 ml label
(click image for full-size original)
image of tube 200 ml label
(click image for full-size original)

image of carton 200ml labelimage of tube 60 ml labelimage of tube 200 ml label Keep out of reach of children.

CLEAR UP CLEANSING salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62499-394
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL BETAINE
TROLAMINE
BUTYLENE GLYCOL
DISODIUM LAURYL SULFOSUCCINATE
METHYL GLUCETH-20
GLYCERIN
POLYOXYL 40 HYDROGENATED CASTOR OIL
SODIUM GLYCOLATE
SODIUM COCOYL ISETHIONATE
PHENOXYETHANOL
CARBOMER COPOLYMER TYPE A
ORANGE OIL
ALMOND OIL
SAGE OIL
LAVANDIN OIL
ETHYLHEXYLGLYCERIN
EDETATE SODIUM
Product Characteristics
Color blue (dark blue) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62499-394-11 1 TUBE (TUBE) in 1 BOX contains a TUBE (62499-394-09)
1 NDC:62499-394-09 200 g in 1 TUBE This package is contained within the BOX (62499-394-11)
2 NDC:62499-394-12 1 TUBE (TUBE) in 1 KIT contains a TUBE (62499-394-08)
2 NDC:62499-394-08 60 g in 1 TUBE This package is contained within the KIT (62499-394-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 06/28/2010
Labeler — Laboratoire Dr. Renaud (202501565)
Registrant — Laboratoire Dr. Renaud (202501565)
Establishment
Name Address ID/FEI Operations
Laboratoire Dr. Renaud 202501565 manufacture

Revised: 06/2010 Laboratoire Dr. Renaud

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