NDC Code(s) : 49825-116-01, 49825-116-02
Packager : Bioelements, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bioelements Benzoyl Peroxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49825-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE(UNII: W9WZN9A0GM)
(BENZOYL PEROXIDE - UNII:W9WZN9A0GM) 		BENZOYL PEROXIDE2.5 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
SQUALENE(UNII: 7QWM220FJH)
POLYSORBATE 60(UNII: CAL22UVI4M)
FYTIC ACID(UNII: 7IGF0S7R8I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49825-116-021 in 1 BOX
1NDC:49825-116-0129 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 01/01/2009

PRINCIPAL DISPLAY PANEL

Bioelements

Breakout Control

Emergency Blemish Lotion with Benzoyl Peroxide


29 mL/ 1 Fl. Oz.




image of front artwork






image of front artwork