PROACTIV EXTRA STRENGTH FORMULA TONER- salicylic acid liquid 
Alchemee, 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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Proactiv Extra Strength Formula Toner
Salicylic Acid Acne Treatment

Active ingredients

Salicylic Acid 2%

Purpose

Acne treatment

Use

For the management of acne

Warnings

For external use only

When using this product

  • skin irritation and dryness are 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.
  • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn.  Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Stop use and ask a doctor if
▪ irritation becomes severe.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.
  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one or 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.

Inactive Ingredients

water, alcohol denat, hamamelis virginiana (witch hazel) extract, glycolic acid, ammonium hydroxide, polysorbate 20, sodium benzoate, imidazolidinyl urea, disodium EDTA

Questions or comments?
Within US 1-800-950-4695

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

proactiv®

EXTRA STRENGTH
FORMULA

toner

2

salicylic acid acne medication

4 FL. OZ. 120 mL

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245 ● proactive.com
Made in the USA of Foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.

Proactiv Extra Strength Formula Toner Carton
PROACTIV EXTRA STRENGTH FORMULA TONER 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS)  
Glycolic Acid (UNII: 0WT12SX38S)  
Ammonia (UNII: 5138Q19F1X)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Imidurea (UNII: M629807ATL)  
Edetate Disodium (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-054-001 in 1 CARTON01/01/200310/15/2023
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/200310/15/2023
Labeler - Alchemee, LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm Inc.049121643manufacture(11410-054)

Revised: 12/2022
 
Alchemee, LLC