Benzoyl Peroxide Emollient

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]

BENZOYL PEROXIDE EMOLLIENT- benzoyl peroxide aerosol, foam 
TAGI Pharma 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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Benzoyl Peroxide Emollient

Drug Facts

Active ingredient (in each gram)

Benzoyl Peroxide 98 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 and water.
  • If going outside, apply sunscreen after using this product.

Other information

  • Store at room temperature 15º - 25º C (59º - 77º 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: 51224-401-10
Compare to the active ingredient in BenzeFoam™*

tagiPHARMA
That's A Good Idea

Benzoyl Peroxide
9.8%
Emollient Foam

Net Weight 3.5 oz (100 g)
Acne Medication

Principal Display Panel - 100 g Can Label
BENZOYL PEROXIDE EMOLLIENT 
benzoyl peroxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51224-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide98 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
norflurane (UNII: DH9E53K1Y8)  
1,1-difluoroethane (UNII: 0B1U8K2ME0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51224-401-011 in 1 CARTON10/11/201301/31/2020
15 g in 1 CAN; Type 0: Not a Combination Product
2NDC: 51224-401-101 in 1 CARTON10/11/201301/31/2020
2100 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/11/201301/31/2020
Labeler - TAGI Pharma Inc. (963322560)

Revised: 2/2020
 
TAGI Pharma Inc.