BENZOYL PEROXIDE EMOLLIENT- benzoyl peroxide aerosol, foam

Benzoyl Peroxide Emollient by

Drug Labeling and Warnings

Benzoyl Peroxide Emollient by is a Otc medication manufactured, distributed, or labeled by TAGI Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gram)

Benzoyl Peroxide 53 mg

Purpose

Acne Medication

Uses

For the treatment of acne

Warnings

For external use only. Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Keep out of reach of children.

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide.

When using this product

• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair, and dyed fabrics, which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

• irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean the skin thoroughly before applying this product

Prime can before initial use:

• Shake can vigorously.
• Hold can upright over sink.
• Direct initial spray to a non-skin surface.
• Press down on the actuator.

Before each use: Shake vigorously.

During use:

• Holding can upright, dispense Benzoyl Peroxide Emollient Foam into palm of hand and apply to affected area once daily, or as directed by doctor.

After use:

• Wipe off any excess foam from actuator.
• Wash hands with soap andwater.
• If going outside, apply sunscreen after using this product.

Other information

• Store at room temperature 15° - 25° C (59° - 77° F)
• Protect from freezing
• Store upright

Inactive ingredients

BHT, C12-15 alkyl benzoate, cetearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, hydrofluorocarbon 152a, methylparaben, propylene glycol, propylparaben, sodium citrate, steareth-10, water

Questions?

www.tagipharma.com

PRINCIPAL DISPLAY PANEL - 100 g Can Label

NDC: 51224-400-10
Compare to the active ingredient in BenzeFoam™*

tagiPHARMA
That's A Good Idea.

Benzoyl Peroxide
Emollient Foam

5.3%

Net Weight 3.5 oz (100 g)
Acne Medication

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE EMOLLIENT 
benzoyl peroxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51224-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	53 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
cetostearyl alcohol (UNII: 2DMT128M1S)
citric acid monohydrate (UNII: 2968PHW8QP)
dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
steareth-10 (UNII: FD0913P475)
1,1-difluoroethane (UNII: 0B1U8K2ME0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51224-400-01	1 in 1 CARTON	10/11/2013	08/31/2020
1		5 g in 1 CAN; Type 0: Not a Combination Product
2	NDC: 51224-400-06	1 in 1 CARTON	10/11/2013	11/30/2018
2		60 g in 1 CAN; Type 0: Not a Combination Product
3	NDC: 51224-400-10	1 in 1 CARTON	10/11/2013	08/31/2020
3		100 g in 1 CAN; 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	10/11/2013	08/31/2020

Labeler - TAGI Pharma Inc. (963322560)