CLEARASIL STUBBORN ACNE CONTROL 5IN1 WEEKLY SCRUB- salicylic acid lotion

Clearasil Stubborn Acne Control 5in1 Weekly Scrub by

Drug Labeling and Warnings

Clearasil Stubborn Acne Control 5in1 Weekly Scrub 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 2%

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
• 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, Laureth-3, Sodium Laureth Sulfate, Hydrated Silica, Niacinamide, Sodium Lactate, Sodium Cocoamphoacetate, Sorbitol, Hexyldecanol, Sodium Chloride, Fragrance, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Bisabolol, Dipotassium Glycyrrhizinate, Benzyl Salicylate, Brassica Campestris (Rapeseeed) Sterols, Cetylhydroxyproline Palmitamide, Stearic Acid, Polyquaternium-43, Phenoxyethanol, Sodium Benzoate, Sodium Sulfate, FD&C Blue 1, FD&C Yellow 6

Questions?

1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

Clearasil®

STUBBORN ACNE
CONTROL 5IN1

WEEKLY SCRUB

Salicylic Acid Acne Medication

FIGHTS
5
STUBBORN
ACNE
PROBLEMS

FIGHTS 1. BLOCKED PORES 2. PIMPLE SIZE
3. EXCESS OIL 4. ACNE MARKS 5. BLACKHEADS

5 fl oz (150 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL STUBBORN ACNE CONTROL 5IN1 WEEKLY SCRUB 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-441
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Cocoyl Isethionate (UNII: 518XTE8493)
Glycerin (UNII: PDC6A3C0OX)
Cetyl Alcohol (UNII: 936JST6JCN)
Laureth-3 (UNII: F32E4CB0UJ)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Hydrated Silica (UNII: Y6O7T4G8P9)
Niacinamide (UNII: 25X51I8RD4)
Sodium Lactate (UNII: TU7HW0W0QT)
Sodium Cocoamphoacetate (UNII: W7Q5E87674)
Sorbitol (UNII: 506T60A25R)
Hexyldecanol (UNII: 151Z7P1317)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Levomenol (UNII: 24WE03BX2T)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Benzyl Salicylate (UNII: WAO5MNK9TU)
Rapeseed Sterol (UNII: B46B6DD20U)
Cetylhydroxyproline palmitamide (UNII: 74ONU0S62G)
Stearic Acid (UNII: 4ELV7Z65AP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Sulfate (UNII: 0YPR65R21J)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Yellow No. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-441-01	150 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)