CLEARASIL GENTLE PREVENTION DAILY CLEAN WASH- salicylic acid lotion

Clearasil Gentle Prevention Daily Clean Wash by

Drug Labeling and Warnings

Clearasil Gentle Prevention Daily Clean Wash by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 1%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

When using this product

• avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.
• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• limit use to the face and neck

Stop use and ask a doctor if skin or eye irritation develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet face
• dispense product into hands, lather and massage gently onto face and neck, avoiding the delicate eye area
• rinse thoroughly with warm water one to three times daily and gently pat dry
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

• keep tightly closed
• store in a cool, dry place

Inactive ingredients

Water, Sodium Cocoyl Isethionate, Glycerin, Cetyl Alcohol, Sodium Lauroyl Sarcosinate, Stearyl Alcohol, Cocamidopropyl Betaine, Steareth-21, Steareth-2, Coco-Glucoside, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Niacinamide, Aloe Barbadensis Leaf Juice, Disodium EDTA, Butylene Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Potassium Sorbate, Sodium Benzoate

Questions?

1-866-25-CLEAR (1-866-252-5327). You may also report side effects to this phone number.

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Distributed by:
RB Health (US),
Parsippany, NJ 07054-0224
Made in Brazil

PRINCIPAL DISPLAY PANEL - 192 mL Tube Label

Clearasil®

GENTLE PREVENTION
DAILY CLEAN

WASH

Salicylic Acid Acne Medication

TREATS
PIMPLES
WEEKS
BEFORE
THEY'RE VISIBLE

TREAT PIMPLES BELOW THE SKIN'S SURFACE
AS SOON AS THEY START FORMING

6.5 fl oz (192 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL GENTLE PREVENTION DAILY CLEAN WASH 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-443
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
COCO GLUCOSIDE (UNII: ICS790225B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NIACINAMIDE (UNII: 25X51I8RD4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CUCUMBER (UNII: YY7C30VXJT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-443-01	192 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/01/2017

Labeler - RB Health (US) LLC (081049410)