SLMD AM BENZOYL PEROXIDE ACNE TREATMENT- benzoyl peroxide gel

SLMD AM Benzoyl Peroxide Acne Treatment by

Drug Labeling and Warnings

SLMD AM Benzoyl Peroxide Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Owen Biosciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzoyl Peroxide 2.5%

Use

for the management of acne

WarningsFor external use only 

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.

• 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 this product less frequently or in a lower concentration

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
• cover the entire affected area with a thin layer one to three times daily

PURPOSE

acne treatment      

DOSAGE & ADMINISTRATION

topical cleanser

Inactive ingredients

Water (Aqua)
Behenoxy Dimethicone
Cyclohexasiloxane
Cyclopentasiloxane
Dimethicone
Glyceryl Stearate SE
Acetyl Carboxymethyl Cocoyl-Glycine
Lysozyme
Phenoxyethanol
Tocopheryl Acetate
Decylene Glycol
Maltodextrin
Glyceryl Stearate
PEG-100 Stearate
Caprylyl Glycol
C13-14 Isoparaffin
Laureth-7
Polyacrylamide
Sodium Carboxymethyl Betaglucan
Cocoglycerides
Glycerin
Lecithin
Palmitoyl Myristyl Serinate
Syringa Vulgaris (Lilac) Extract
Butylene Glycol
Propanediol
Mirabilis Jalapa Extract
Aloe Barbadensis Leaf Juice
Capryloyl Glycine
Polyglyceryl-10 Laurate
Tromethamine
Beta-Glucan
Myristoyl Tetrapeptide-13
Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Do not use if

• have very senstive skin
• are sensitive to benzoyl peroxide

Stop us and ask a doctor if

irritation becomes severe

Acne Lotion Back.jpg

Acne Lotion Back.jpg

INGREDIENTS AND APPEARANCE

SLMD AM BENZOYL PEROXIDE ACNE TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-402
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	70.14 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O)	3.8 g  in 100 g
Glyceryl Stearate SE (UNII: FCZ5MH785I)	2 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-402-01	1 in 1 PACKAGE	03/24/2017
1		50 g 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	03/22/2017

Labeler - Owen Biosciences, Inc. (790003045)

Registrant - Owen Biosciences, Inc. (790003045)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences, Inc.		790003045	manufacture(59958-402)