NDC Code(s) : 67234-007-01
Packager : Natureplex, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne TreatmentSALICYLIC ACID GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-007
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 ACID5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DMDM HYDANTOIN(UNII: BYR0546TOW)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)(UNII: L605B5892V)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67234-007-011 in 1 BOX 01/02/2007
142 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 01/02/2007

LABELER - Natureplex, LLC(062808196)

Establishment
Name Address ID/FEI Business Operations
Natureplex, LLC 062808196 MANUFACTURE(67234-007)

PRINCIPAL DISPLAY PANEL

Natureplex™

Acne
Treatment
Clear Gel

NET WT. 1.5 Oz.(42.5g)

Principal Display Panel - 42.5 g Tube Box