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 Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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.
  

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: 64760-719
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
.BETA.-ELEOSTEARIC ACID (UNII: LA17B88161)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
CITRUS FRUIT (UNII: XDK00Z8012)
1-CHLORO-2-METHYL-1-PROPENE (UNII: JP8N4M44OP)
LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)
SODIUM HYDROXYPROPYLSULFONATE LAURYLGLUCOSIDE-7 CROSSPOLYMER (UNII: K9R4VJQ1IB)
1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)
ISOSTEARAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE (UNII: U059JNZ17L)
ISOEICOSANE (UNII: AR294KAG3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DICLOFENAC SODIUM (UNII: QTG126297Q)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
POLYGLUCOSE SORBITOL CARBOXYMETHYL ETHER (UNII: Y8P5S7CF2S)
CARBAZOCHROME SODIUM SULFONATE HYDRATE (UNII: Y6G4426VGB)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CARRAGEENAN (UNII: 5C69YCD2YJ)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ)
ETHYL PERFLUOROISOBUTYL ETHER (UNII: G60AS0OTNS)
DIMETHICONE PEG-8 ADIPATE (UNII: 09Y0SJ39VP)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
ACETYL ARGININE (UNII: TQ7DL04CAE)
ETHYL PERFLUOROBUTYL ETHER (UNII: 520BW6FQ5U)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ISOHEXADECANE (UNII: 918X1OUF1E)
1,3-BUTYLENE GLYCOL 1-PROPIONATE (UNII: 17U77WTV66)
MALTOOLIGOSYL GLUCOSIDE (UNII: N91S91EFOG)
INDOL-3-YL SODIUM PHOSPHATE (UNII: P1W2D6403E)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
LAMINARIA DIGITATA HYDROLYZED ALGINIC ACID (UNII: 9E3P882579)
DISODIUM LAUROYL GLUTAMATE (UNII: O99ROV57IA)
CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
DISODIUM ASCORBYL SITOSTANOL PHOSPHATE (UNII: 3H8J8917AA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-719-01	1 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	11/09/2020	01/22/2025

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)