ACNE TREATMENT SYSTEM- benzoyl peroxide, salicylic acid kit

Acne Treatment System by

Drug Labeling and Warnings

Acne Treatment System by is a Otc medication manufactured, distributed, or labeled by Vivier Pharma, Inc., Dermolab Pharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active ingredient

Salicylic Acid USP 2%

Purpose

Acne treatment

Use

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

Warnings

For external use only.

Ask a doctor before use if you are

using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product

do not get into eyes.

Stop use and ask a doctor if

excessive skin irritation develops or increases.

Keep out of reach of children.

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

Directions

Wet face using lukewarm water.
Gently massage over face using fingertips.
Rinse completely.
Use both morning and night or as directed by a physician.
If dryness or peeling occurs, reduce application to once a day or every other day.

Other information

Store at room temperature (15-30°C / 59-86°F).

Inactive ingredients

Acrylates Copolymer, Alcohol, Citric Acid, Disodium Cocoamphodiacetate, Disodium Cocoyl Glutamate, DMDM Hydantoin, Ethoxydiglycol, Fragrance, Hexamidine Diisethionate, PEG-7 Glyceryl Cocoate, PEG-120 Methyl Glucose Dioleate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Water/Eau.

Questions?

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Package Labeling:

INGREDIENTS AND APPEARANCE

ACNE TREATMENT SYSTEM 
benzoyl peroxide, salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67226-3026

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-3026-9	1 in 1 KIT	11/11/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	30 mL
Part 2	1 BOTTLE, PUMP	150 mL

Part 1 of 2

ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Item Code (Source)	NDC: 67226-2050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LANOLIN OIL (UNII: OVV5IIJ58F)
LAURETH-4 (UNII: 6HQ855798J)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-2050-3	1 in 1 BOX
1		30 mL in 1 TUBE; 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	11/01/2011

Part 2 of 2

MEDICATED WASH 
salicylic acid liquid

Product Information
Item Code (Source)	NDC: 67226-1021
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
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-1021-1	150 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	11/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/11/2017

Labeler - Vivier Pharma, Inc. (250996550)

Establishment
Name	Address	ID/FEI	Business Operations
Dermolab Pharma Ltd		245414743	manufacture(67226-3026, 67226-2050, 67226-1021)