SLMD AM BENZOYL PEROXIDE ACNE TREATMENT- benzoyl peroxide gel 
Owen Biosciences, 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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SLMD AM Benzoyl Peroxide Acne Treatment

Active Ingredients

Benzoyl Peroxide 2.5%

Use

for the management of acne

Warnings
For 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.


Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

acne treatment      

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

Stop us and ask a doctor if

irritation becomes severe

Acne Lotion Back.jpg

Acne Lotion Back.jpg

image description

SLMD AM BENZOYL PEROXIDE ACNE TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-402-011 in 1 PACKAGE03/24/2017
150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/22/2017
Labeler - Owen Biosciences, Inc. (790003045)
Registrant - Owen Biosciences, Inc. (790003045)
Establishment
NameAddressID/FEIBusiness Operations
Owen Biosciences, Inc.790003045manufacture(59958-402)

Revised: 1/2023
Document Id: f267a49e-2622-0768-e053-2a95a90a8258
Set id: a6c1701d-b59a-41ae-b4f3-725cc59522fe
Version: 4
Effective Time: 20230116
 
Owen Biosciences, Inc.