GLYTONE ACNE CLEANSING TONER- salicylic acid solution
Genesis Pharmaceutical, Inc.

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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Glytone acne treatment acne cleansing toner

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Use

For the treatment of acne.

penetrates pores to control acne blemishes.
helps keep skin clear of new acne blemishes.

Warnings

For external use only

When using this product

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
avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
flammable - keep away from open fire or flame.

Stop use and ask a doctor if

rash or irritation develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control center immediately.

Directions

Cleanse skin thoroughly before applying.
Moisten a cotton ball and cover the affected area with a thin layer one to three times a day. 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

Acetone, Benzalkonium Chloride, Fragrance, Isopropyl Alcohol, Polysorbate 20, Red 40, Water, Yellow 5.

Principal Display Panel - 240 mL Carton

GLYTONE

ACNE

treatment

acne cleansing

toner

2% SALICYLIC ACID

240 mL / 8 FL. OZ.

GLYTONE ACNE CLEANSING TONER
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64760-205
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	4.8 g in 240 mL

Ingredient Name	Strength
Inactive Ingredients
ACETONE (UNII: 1364PS73AF)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64760-205-01	1 in 1 CARTON	01/01/2010	01/20/2018
1		240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	01/01/2010	01/20/2018

Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 8/2016

Document Id: aceeb2a2-fe06-41a6-bdbc-8afa09a300d1

Set id: 19c8dec4-b688-44d4-ac5a-1e3db9f068a4

Version: 6

Effective Time: 20160803

Genesis Pharmaceutical, Inc.