CLEARASIL ULTRA ACNE PLUS MARKS DAILY SCRUB- salicylic acid lotion

Clearasil by

Drug Labeling and Warnings

Clearasil by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser 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

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 and massage gently onto face and neck, avoiding the delicate eye area
• cover the entire affected area with a thin layer and 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 occurs, reduce application to once a day or every other day

Other information

• keep tightly closed
• store at 20-25°C (68-77°F)

Inactive ingredients

water, sodium cocoyl isethionate, glycerin, cetyl alcohol, laureth-3, polyethylene, sodium laureth sulfate, sodium cocoamphoacetate, niacinamide, sodium lactate, sorbitol, hexyldecanol, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, dipotassium glycyrrhizate, disodium EDTA, bisabolol, cetylhydroxyproline palmitamide, stearic acid, polyquaternium-43, Brassica campestris (rapeseed) sterols, phenoxyethanol, sodium benzoate, FD&C blue no. 1, FD&C yellow no. 6

Questions?

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

You may also report side effects to this phone number

SPL UNCLASSIFIED SECTION

Distributed by:
Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in USA

PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

Clearasil®

ULTRA

Acne + Marks
Daily Scrub
Salicylic Acid 2% Acne Medication

REDUCES
MARKS

Helps clear
pimples fast,
and reduces the
appearance of
acne marks

5.0 FL OZ (150 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL   ULTRA ACNE PLUS MARKS DAILY SCRUB
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-420
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)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SORBITOL (UNII: 506T60A25R)
HEXYLDECANOL (UNII: 151Z7P1317)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LEVOMENOL (UNII: 24WE03BX2T)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
STEARIC ACID (UNII: 4ELV7Z65AP)
RAPESEED STEROL (UNII: B46B6DD20U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
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: 63824-420-65	150 mL in 1 TUBE; Type 0: Not a Combination Product	12/22/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/22/2014

Labeler - Reckitt Benckiser LLC (094405024)