Clearasil® UltraRapid Action Daily Gel Wash

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL ULTRA  RAPID ACTION DAILY WASH- salicylic acid gel 
RB Health (US) LLC

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.

----------

Clearasil® Ultra
Rapid Action Daily Gel Wash

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 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

• store in a cool, dry place
• do not store in direct sunlight

Inactive ingredients

water, glycerin, sodium laureth sulfate, coco-glucoside, cocamidopropyl betaine, PEG-200 hydrogenated glyceryl palmate, sodium chloride, laureth-4, PEG-7 glyceryl cocoate, polyquaternium-43, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, sodium hydroxide, phenoxyethanol, sodium benzoate, FD&C blue no. 1

Questions?

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

You may also report side effects to this phone number.

Distributed by: Reckitt Benckiser LLC Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

Clearasil®

ULTRA

Rapid Action
Daily Gel Wash
Salicylic Acid 2% Acne Medication

12
HOURS

Visibly
clearer
skin in as
little as
12 hours

071212

8040108

6.78 FL OZ (200 mL)

CLEARASIL ULTRA   RAPID ACTION DAILY WASH
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-381
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)
glycerin (UNII: PDC6A3C0OX)
sodium laureth-3 sulfate (UNII: BPV390UAP0)
coco glucoside (UNII: ICS790225B)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
sodium chloride (UNII: 451W47IQ8X)
laureth-4 (UNII: 6HQ855798J)
PEG-7 glyceryl cocoate (UNII: VNX7251543)
helichrysum italicum flower (UNII: P62Y550X24)
sodium hydroxide (UNII: 55X04QC32I)
phenoxyethanol (UNII: HIE492ZZ3T)
sodium benzoate (UNII: OJ245FE5EU)
FD&C blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-381-67	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/21/2012	09/02/2019
2	NDC: 63824-381-03	3 mL in 1 PACKET; Type 0: Not a Combination Product	07/21/2012	09/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/21/2012	09/02/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019

Document Id: 0791e15b-eda6-4293-ab57-d7f129d8459e

34390-5

Set id: 32c030c1-7a21-4536-8788-19e5b0941003

Version: 3

Effective Time: 20190927