SLMD SPOT TREATMENT- benzoyl peroxide gel

SLMD Spot Treatment by

Drug Labeling and Warnings

SLMD Spot 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 10%

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 product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor.

PURPOSE

acne treatment      

DOSAGE & ADMINISTRATION

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

• have very senstive skin
• are sensitive to benzoyl peroxide

Stop us and ask a doctor if

irritation becomes severe

PRINCIPAL DISPLAY PANEL

Acne Spot Treatment Back.jpg

INGREDIENTS AND APPEARANCE

SLMD SPOT TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-401
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	51.90 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)	3.0 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-401-01	1 in 1 PACKAGE	03/24/2017
1		15 g in 1 TUBE; 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(59958-401)