CLEARASIL ULTRA ACNE PLUS MARKS TREATMENT- salicylic acid solution 
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.

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Clearasil ®

Ultra Acne + Marks Treatment Lotion

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 eyes and mouth. If contact occurs, rinse thoroughly with water.
  • using other topical acne medications at the same time or immediately following use of this product, may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by your doctor.
  • limit use to the face & neck, chest and back

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 immediately.

Directions

  • cleanse the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 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

  • store in a cool, dry place

Inactive ingredients

water, butylene glycol, octyldodecanol, steareth-2, cetyl alcohol, steareth-21, dimethicone, polyacrylamide, glycerin, C13-14 isoparaffin, sodium hydroxide, xanthan gum, magnesium aluminum silicate, laureth-7, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract, titanium dioxide

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

Clearasil®

ULTRA

Acne+Marks
Treatment Lotion
Salicylic Acid 2% Acne Medication

REDUCES
MARKS

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

4 FL. OZ. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label
CLEARASIL  ULTRA ACNE PLUS MARKS TREATMENT
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-422
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
STEARETH-2 (UNII: V56DFE46J5)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARETH-21 (UNII: 53J3F32P58)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
LAURETH-7 (UNII: Z95S6G8201)  
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-422-01118 mL in 1 TUBE; Type 0: Not a Combination Product08/01/201509/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/01/201509/01/2020
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2023
 
RB Health (US) LLC