NDC Code(s) : 57627-201-01, 57627-201-02
Packager : Merle Norman Cosmetics, Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne Defense Spot Treatment Salicylic Acid GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID2 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
1NDC:57627-201-021 in 1 CARTON 14/07/2017
1NDC:57627-201-0114 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 Drug M006 07/14/2017

LABELER - Merle Norman Cosmetics, Inc(008479388)

PRINCIPAL DISPLAY PANEL

ACNE DEFENSE

SPOT TREATMENT

ACNE TREATMENT GEL   

merle norman

14g e

NET WT. .50 OZ.

label

label