NDC Code(s) : 69753-002-00
Packager : Worldceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Element 47 Face and Body Acne TreatmentSalicylic Acid SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69753-002
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 mL
Inactive Ingredients
Ingredient Name Strength
PROPANEDIOL(UNII: 5965N8W85T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
GLYCERIN(UNII: PDC6A3C0OX)
ALLANTOIN(UNII: 344S277G0Z)
PUMMELO(UNII: ET1TN5W71X)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
EDETATE SODIUM(UNII: MP1J8420LU)
PEG/PPG-4/12 DIMETHICONE(UNII: JAN3585W85)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69753-002-001 in 1 CARTON
1240 mL in 1 BOTTLE, SPRAY 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 04/10/2015

PRINCIPAL DISPLAY PANEL

ELEMENT 47

FACE & BODY

ACNE TREATMENT

FACE & BODY

ACNE TREATMENT

FORMULATED FOR

SENSITIVE SKIN TYPES

8 FL. OZ. (240ML)

Bottle

Bottle