NEUTRALYZE CLEARING SERUM- salicylic acid gel 
Kantian Skincare, 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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Drug Facts

Active Ingredient

Salicylic acid 2%

Purpose

Acne treatment

Use

for the treatment 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 unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid unnecessary sun exposure and use a sunscreen of SPF15 or higher.

Do not use if you have very sensitive skin or are sensitive to salicylic acid.

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 these directions: cover the entire affected area with a thin layer one to three times daily. Do not rinse off. Because excessive drying or skin irritation may occur, start with one application daily, then gradually increase to two to three times daily if needed or directed by a doctor. If bothersome dryness, peeling or irritation occurs, reduce application to once a day or every other day.

Inactive Ingredients:

WATER, ALCOHOL, DIMETHICONE, BETAINE, 1,2-HEXANEDIOL, MANDELIC ACID, POLYACRYLATE CROSSROLYMER-6,DEHYDROXANTHAN GUM, PHENOXYETHANOL, AMMONIA, T-BUTYL ALCOHOL, DENATONIUM BENZOATE, BLUE 1 (CL 42090)

Principal Display Panel – Bottle Label.

neutralyze®

NEUTRALYZE CLEARING SERUM

SKIN REPAIRING

ACNE TREATMENT GEL

STEP 2 – REPAIR

CLEARS ACNE, FADES DARK SPOTS
& CORRECTS UNEVEN SKIN TONE

CONTROLS OIL, UNCLOGS &
REDUCES THE SIZE OF PORES

1.52 FL. OZ./45 mL

Principal Display Panel – Bottle Label
NEUTRALYZE CLEARING SERUM 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57524-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Dimethicone (UNII: 92RU3N3Y1O)  
Betaine (UNII: 3SCV180C9W)  
1,2-hexanediol (UNII: TR046Y3K1G)  
Mandelic Acid (UNII: NH496X0UJX)  
Ammonium Acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) (UNII: Q7UI015FF9)  
Dehydroxanthan Gum (UNII: 63ZP7I1BQO)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ammonia (UNII: 5138Q19F1X)  
Tert-Butyl Alcohol (UNII: MD83SFE959)  
Denatonium Benzoate (UNII: 4YK5Z54AT2)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57524-015-0145 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/15/2020
Labeler - Kantian Skincare, LLC (078436984)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc624386772MANUFACTURE(57524-015)

Revised: 1/2023
Document Id: c52b41b9-8f8b-4430-bfd1-dcd04fb2a3bd
Set id: 764fa818-4412-490e-af6f-2cccb8736cc7
Version: 3
Effective Time: 20230125
 
Kantian Skincare, LLC