SLMD ACNE CLEANSER- salicylic acid gel

SLMD Acne Cleanser by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Salicylic Acid 0.5%

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.

Keep out of reach of children.

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

Directions

use twice daily, morning and night

apply small amount to dampened skin and gently massage for 1 to 2 minutes

rinse thoroughly with warm water and pat dry

for best results follow with SLMD Acne Lotion for daytime use or SLMD Clarifying Treatment for nighttime use, then follow with SLMD Facial Moisturizer

Sensitivity test for a New User: Apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follow directions above. 

Other information

Store in a cool, dry place

PURPOSE

acne treatment      

DOSAGE & ADMINISTRATION

topical cleanser

Inactive ingredients

Acetyl CarboxyMethyl Cocyl Glycine
Avena Sativa (Oat) Kernel Extract
Beta-Glucan
Bisabolol
Caprylyl Glycol
Cocamidopropyl Betaine
Disodium EDTA
Disodium Laureth Sulfosuccinate
Eucalyptus Globulus Leaf Oil
Glycerin
Menthol
Myristoyl Tetrapeptide-13
Phenoxyethanol
Potassium Hydroxide
Sodium Cocoyl Isethionate
Sodium Lauroamphoacetate
Sodium Methyl Cocoyl Taurate
Water (Aqua)
Xanthan Gum
Zingiber Officinale (Ginger) Root Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SLMD ACNE CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-400
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	82.42 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	3 g  in 100 g
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)	3 g  in 100 g
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)	2.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-400-01	1 in 1 PACKAGE	03/24/2017
1		125 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(59958-400)