GLYTONE ACNE SELF-FOAMING CLEANSER- salicylic acid gel

Glytone Acne Self-Foaming Cleanser by

Drug Labeling and Warnings

Glytone Acne Self-Foaming Cleanser by is a Otc medication manufactured, distributed, or labeled by Genesis Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Salicylic Acid 0.5% Acne Treatment

PURPOSE

Acne treatment

INDICATIONS & USAGE

Use For the treatment of acne.

• Dries and clears acne blemishes and allows skin to heal.
• Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads.
• Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

WARNINGS

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.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

• At initial use, turn pump head counter-clockwise to unlock.
• Dispense a small amount into your hand and mix with a little water.
• Apply a thin layer over entire affected area in a circular motion and rinse thoroughly with warm water two times daily. For a mask-like effect, leave on for 30 seconds before rinsing.
• Because of excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 INGREDIENT

Water, Methyl Perfluoroisobutyl Ether, Butylene Glycol, Sorbitol, Methyl Perfluorobutyl Ether, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Chondrus Crispus (Carrageenan), Cyclopentasiloxane, Cyclohexasilioxane, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyhydroxystearic acid, Isononyl Isononanoate, Ethylhexyl Isononanoate, Xanthan Gum, Sodium Hydroxide, Perfluorohexane, o-Cymen-5-ol, Tetrasodium EDTA, Cinnamomum Zeylanicum Bark Extract, Oryza Sativa (Rice) Bran Extract, Yeast Polysaccharides, Blue 1 (CI 42090)

PRINCIPAL DISPLAY PANEL

Glytone Acne Self-Foaming Cleanser

0.5 salicylic acid

non-irritating formula

180 ml/6.1 fl oz

INGREDIENTS AND APPEARANCE

GLYTONE ACNE SELF-FOAMING CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PERFLEXANE (UNII: FX3WJ41CMX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITOL (UNII: 506T60A25R)
BETAINE (UNII: 3SCV180C9W)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)
YEAST (UNII: 3NY3SM6B8U)
RICE BRAN (UNII: R60QEP13IC)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYL PERFLUOROBUTYL ETHER (UNII: H637A50B7U)
CINNAMON BARK OIL (UNII: XE54U569EC)
METHYL PERFLUOROISOBUTYL ETHER (UNII: HI89P35AAX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-303-02	1 in 1 CARTON	09/16/2015
1		180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/16/2015	05/31/2021

Labeler - Genesis Pharmaceutical, Inc. (117196928)

Registrant - Genesis Pharmaceutical, Inc. (117196928)