BPO

BPO — benzoyl peroxide gel
Acella Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

BPO 4% Gel and BPO’8% Gel are topical preparations containing benzoyl peroxide 4% and 8%, respectively, as the active ingredient in a gel vehicle containing purified water, aloe barbadensis leaf juice, benzyl alcohOl, cetyl alcohol, dimethyl isosorbide, simethicone, stearyl alcohol and ceteareth-20.

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyd peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

BPO 4% Gel and BPO 8% Gel are indicated for use in the topical treatment of mild to moderate acne vulgaris. BPO 4% Gel or BPO 8% Gel may be used as an addition in acne treatment regimens including antibiotics, retinoic acid products and sulfur/salicylic acid containing preparations.

BPO 4% Gel and BPO 8% Gel should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.

Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1 000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use .

BPO 4% Gel is supplied in 42.5 g (1.5 oz) tubes NDC42192-1 05-15. BPO 8% Gel is supplied in 42.5 9 (1.5 oz) tubes NDC 421 92-106-15.
Store at controlled room temperature 15°-30°C (59°·86°F).

Tube
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U Carton
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BPO
benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-105
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 4 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
DIMETHYL ISOSORBIDE
CETYL ALCOHOL
STEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42192-105-15 1 TUBE in 1 PACKAGE contains a TUBE
1 42500 mg in 1 TUBE This package is contained within the PACKAGE (42192-105-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/09/2008 02/29/2020
Labeler — Acella Pharmaceuticals, LLC (825380939)
Registrant — Harmony Labs, Inc. (105803274)
Establishment
Name Address ID/FEI Operations
Harmony Labs, Inc. 105803274 manufacture (42192-105), label (42192-105), pack (42192-105), relabel (42192-105), repack (42192-105)

Revised: 09/2018 Acella Pharmaceuticals, LLC

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