CLEARASIL ULTRA ACNE PLUS MARKS DAILY SCRUB- salicylic acid lotion

Clearasil Ultra by

Drug Labeling and Warnings

Clearasil Ultra 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

2% Salicylic acid

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 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

• for best results, use twice daily
• wet face
• dispense product into hands, lather and massage over face and neck avoiding eyes
• rinse thoroughly in warm water 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 directed by a doctor
• if bothersome dryness or peeling occurs, reduce the 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 glycrrhizate, disodium EDTA, bisabolol, cetylhydroxyproline palmitamide, stearic acid, polyquaternium-43, brassica campestris (rapeseed) sterols, phenoxyethanol, methylparaben, butylparaben, ethylparaben, isobutylparaben, propylparaben, FD&C blue no. 1, FD&C yellow no. 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: Reckitt Benckiser LLC
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

NEW

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: 63824-395
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 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)
niacinamide (UNII: 25X51I8RD4)
sodium lactate (UNII: TU7HW0W0QT)
sorbitol (UNII: 506T60A25R)
hexyldecanol (UNII: 151Z7P1317)
sodium hydroxide (UNII: 55X04QC32I)
Edetate Disodium (UNII: 7FLD91C86K)
levomenol (UNII: 24WE03BX2T)
cetylhydroxyproline palmitamide (UNII: 74ONU0S62G)
stearic acid (UNII: 4ELV7Z65AP)
rapeseed sterol (UNII: B46B6DD20U)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
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: 63824-395-65	150 mL in 1 TUBE; Type 0: Not a Combination Product	05/04/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/04/2012

Labeler - RB Health (US) LLC (081049410)