CLEAR UP Prep: Package Insert and Label Information

CLEAR UP PREP — 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 • SORBITOL • ETHOXYDIGLYCOL • GLYCOLIC ACID • METHYL GLUCETH-20 • SODIUM CITRATE • GLYCERIN • LACTIC ACID • SODIUM HYDROXIDE • CELLULOSE GUM • XANTHAN GUM • ETHYLHEXYLGLYCERIN • PROPYLENE GLYCOL • PHENOXYETHANOL • CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT • HEDERA HELIX (IVY) EXTRACT • SAPONARIA OFFICINALIS EXTRACT •
ARCTIUM LAPPA ROOT EXTRACT • SALVIA OFFICINALIS (SAGE) LEAF EXTRACT •

DIRCETIONS

Cover the eyes with cotton pads soaked in Blue Water. With the fingertips, apply evenly to the face and neck CLEAR UP Prep Lotion, making sure to avoid the lips.

Application: 2-3 minutes | Pause: 7-8 minutes

WARNINGS

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

image of tube 5ml label
image of tube5ml label
(click image for full-size original)

image of carton labelimage of tube5ml label Keep out of reach of children.
CLEAR UP PREP
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62499-395
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
SORBITOL
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCOLIC ACID
METHYL GLUCETH-20
SODIUM CITRATE
GLYCERIN
LACTIC ACID
SODIUM HYDROXIDE
PROPYLENE GLYCOL
PHENOXYETHANOL
CARBOXYMETHYLCELLULOSE SODIUM
XANTHAN GUM
ETHYLHEXYLGLYCERIN
LEMON OIL
SAPONARIA OFFICINALIS ROOT
ARCTIUM LAPPA ROOT
SAGE OIL
Product Characteristics
Color blue (dark bleu) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62499-395-11 1 TUBE (TUBE) in 1 CARTON contains a TUBE (62499-395-10)
1 NDC:62499-395-10 5 g in 1 TUBE This package is contained within the CARTON (62499-395-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 07/01/2010
Labeler — Laboratoire Dr. Renaud (202501565)

Revised: 07/2010 Laboratoire Dr. Renaud

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