GLYTONE ACNE TREATMENT- salicylic acid lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Pierre Fabre USA Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Treatment 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.
Authorization status:
OTC monograph final
Authorization number:
64760-709-01

GLYTONE ACNE TREATMENT- salicylic acid lotion

Pierre Fabre USA 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 Lotion

Drug Facts

Active Ingredients

Salicylic Acid 1 %

Purpose

Acne Treatment

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

For external use only

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 the eyes. If eye contact occurs, flush thoroughly with water.

Keep out of reach of children.

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

Directions

Cleanse the skin thoroughly before applying medication.

Cover the affected area(s) with a thin layer one to three times daily, or as directed by your

physician.

Because excessive drying of the skin may occur, start with one application daily, then gradually

increase to two to three times daily or as directed by your physician.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other Information

Store at room temperature of 68-77° F (20-25° C).

Store at room temperature of 68-77° F (20-25° C).

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Ethoxydiglycol, Propylene Glycol, Glyceryl

Laurate, PEG-100 Stearate, Cyclopentasiloxane, Cetearyl Glucoside, Behenyl Alcohol, Bisabolol,

Carnosine, Hydrogenated Lecithin, Oryza Sativa (Rice) Bran Extract, Xanthan Gum, Sodium Hydroxide,

Polysilicone-11, Disodium EDTA, Methylparaben, Ethylparaben, Butylparaben,

Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Propylparaben,

Isobutylparaben, Phenoxyethanol

Principal Display Panel

GLYTONE

Acne Treatment Lotion

1.0% Salicylic Acid

NON-IRRITATING FORMULA

NET WT. 56.7 g / 2 OZ.

GLYTONE ACNE TREATMENT

salicylic acid lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 476 0 -70 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

BIS-ETHO XYDIGLYCO L SUCCINATE (UNII: YGQ120 RH3I)

DIMETHICO NE/VINYL DIMETHICO NE CRO SSPO LYMER ( SO FT PARTICLE) (UNII: 9 E4CO0 W6 C5)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

WATER (UNII: 0 59 QF0 KO0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

GLYCERYL LAURATE (UNII: Y9 8 6 11C0 8 7)

CETEARYL GLUCO SIDE (UNII: 0 9 FUA47KNA)

CARNO SINE (UNII: 8 HO6 PVN24W)

HYDRO GENATED SO YBEAN LECITHIN (UNII: H110 9 Z9 J4N)

RICE BRAN (UNII: R6 0 QEP13IC)

XANTHAN GUM (UNII: TTV12P4NEE)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

ETHYLPARABEN (UNII: 14255EXE39 )

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

ACRYLIC ACID (UNII: J9 4PBK7X8 S)

ISO BUTYLPARABEN (UNII: 0 QQJ25X58 G)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

DO CO SANO L (UNII: 9 G1OE216 XY)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

LEVO MENO L (UNII: 24WE0 3BX2T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 476 0 -70 9 -0 1

1 in 1 CARTON

10 /20 /20 17

1

56 .7 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Pierre Fabre USA Inc.

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

10 /20 /20 17

Labeler -

Pierre Fabre USA Inc. (117196928)

Registrant -

Pierre Fabre USA Inc. (117196928)

Revised: 12/2019

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