ACNE DEFENSE SPOT TREATMENT MERLE NORMAN- salicylic acid gel

Acne Defense Spot Treatment by

Drug Labeling and Warnings

Acne Defense Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:                             Purpose

Salicylic Acid 2.0%                             Acne Treatment

PURPOSE

For the treatment of Acne

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Using other topical acne medication at the same tim or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

WARNINGS

• For external use only

DOSAGE & ADMINISTRATION

Cleanse skin thoroughly before applying. Cover the entire affected area with a thing layer 1 to 3 times daily or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT

SD Alcohol 40-B, Aqua/Water/Eau, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Polyacrylate Crosspolymer 6, Laminaria Saccarina Extract, Thermus Thermophillus Ferment, Opuntia Ficus-Indica Stem Extract, Sea Whip Extract, Bisabolol, Glycerin, Pentylene Glycol, Butylene Glycol, Propylene Glycol, Aminomethyl Propanol, 4-t-Butylcyclohexanol, Hydroxyethylcellulose, Hydroxymethoxyphenyl Decanone, Benzalkonium Chloride

PRINCIPAL DISPLAY PANEL

ACNE DEFENSE

SPOT TREATMENT

ACNE TREATMENT GEL   

merle norman

14g e

NET WT. .50 OZ.

INGREDIENTS AND APPEARANCE

ACNE DEFENSE SPOT TREATMENT  MERLE NORMAN
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-201-02	1 in 1 CARTON	07/14/2017
1	NDC: 57627-201-01	14 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	part358H	07/14/2017

Labeler - Merle Norman Cosmetics, Inc (008479388)

Registrant - Merle Norman Cosmetics, Inc (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics, Inc		008479388	manufacture(57627-201)