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Benzoyl Peroxide Emollient by TAGI Pharma Inc.

Medically reviewed on Dec 1, 2017

Dosage form: aerosol, foam
Ingredients: Benzoyl Peroxide 53mg in 1g
Labeler: TAGI Pharma Inc.
NDC Code: 51224-400

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.

Benzoyl Peroxide Emollient

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

BENZOYL PEROXIDE EMOLLIENT 
benzoyl peroxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51224-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide53 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxytoluene 
Alkyl (C12-15) Benzoate 
cetostearyl alcohol 
citric acid monohydrate 
dimethicone 
Edetate Disodium 
glycerin 
methylparaben 
propylene glycol 
propylparaben 
water 
sodium citrate, unspecified form 
steareth-10 
1,1-difluoroethane 
Packaging
#Item CodePackage Description
1NDC:51224-400-011 CAN in 1 CARTON
15 g in 1 CAN
2NDC:51224-400-061 CAN in 1 CARTON
260 g in 1 CAN
3NDC:51224-400-101 CAN in 1 CARTON
3100 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/11/2013
Labeler - TAGI Pharma Inc. (963322560)

 
TAGI Pharma Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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