NEUTRALYZE CLEARING SERUM- salicylic acid gel

Neutralyze Clearing Serum by

Drug Labeling and Warnings

Neutralyze Clearing Serum by is a Otc medication manufactured, distributed, or labeled by Kantian Skincare, LLC, PhytogenX, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

NEUTRALYZE CLEARING SERUM 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57524-015
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57524-015-01	45 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/15/2020

Labeler - Kantian Skincare, LLC (078436984)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc		624386772	MANUFACTURE(57524-015)