SLMD SPOT 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 Moisturizer with SPF

Active Ingredients

Benzoyl Peroxide 10%

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)
Propanediol
Glycerin
Neopentyl Glycol Diethylhexanoate
Dimethicone
Cyclopentasiloxane
Cyclohexasiloxane
Titanium Dioxide
C12-15 Alkyl Benzoate
Stearic Acid
Behenoxy Dimethicone
Behenyl Alcohol
Glyceryl Stearate
PEG-100 Stearate
Myristoyl Tetrapeptide-13
Acetyl Carboxymethyl Cocoyl Glycine
Panthenol
Tocopheryl Acetate
Sodium Hyaluronate
Allatoin
Glyceryl Oleate
Behenic Acid
Steareth-21
Steareth-2
Silica
Carbomer
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Phenoxyethanol
Ethylhexylglycerin
Fragrance
Tromethamine
Alumina
Polyhydroxystearic Acid

Do not use if

Stop us and ask a doctor if

irritation becomes severe

image descriptionAcne Spot Treatment Back.jpg

SLMD SPOT TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 51.9 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T) 5 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 3 g  in 100 g
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) 3 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-401-011 in 1 PACKAGE03/24/2017
115 g in 1 TUBE; 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(59958-401)

Revised: 1/2023
Document Id: f267acca-a7d2-9873-e053-2a95a90a5087
Set id: 8d83ebaa-a292-402b-b239-bd603c52f396
Version: 4
Effective Time: 20230116
 
Owen Biosciences, Inc.