NDC Code(s) : 69318-001-01, 69318-001-02
Packager : DoctorAN

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AN12Allantoin, Glycerin GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69318-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLANTOIN(UNII: 344S277G0Z)
(ALLANTOIN - UNII:344S277G0Z) 		ALLANTOIN0.3 mg in 150 mL
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN3 mg in 150 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(UNII: S38J6RZN16)
SPANISH SARDINE(UNII: V837G5YR4R)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
COCO GLUCOSIDE(UNII: ICS790225B)
Decyl Glucoside(UNII: Z17H97EA6Y)
COCO DIETHANOLAMIDE(UNII: 92005F972D)
CARICA PAPAYA LEAF(UNII: 66J7636Z2I)
HOUTTUYNIA CORDATA FLOWERING TOP(UNII: RH041UUZ22)
NEPIDERMIN(UNII: TZK30RF92W)
RICE BRAN(UNII: R60QEP13IC)
ARTEMISIA VULGARIS ROOT(UNII: 32MP823R8S)
MUNG BEAN(UNII: 1LIB31N73G)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
PURSLANE(UNII: M6S840WXG5)
RHEUM PALMATUM ROOT(UNII: G025DAL7CE)
BAMBUSA VULGARIS TOP(UNII: FIW80T6P6V)
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
HAMAMELIS VIRGINIANA TOP(UNII: UDA30A2JJY)
MATRICARIA RECUTITA FLOWERING TOP(UNII: 3VNC7T6Z02)
PROPOLIS WAX(UNII: 6Y8XYV2NOF)
OLEIC ACID(UNII: 2UMI9U37CP)
PEG-60 CASTOR OIL(UNII: VXP26NM2XX)
POMEGRANATE(UNII: 56687D1Z4D)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Polysorbate 80(UNII: 6OZP39ZG8H)
MENTHOL(UNII: L7T10EIP3A)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69318-001-021 in 1 CARTON 24/10/2014
1NDC:69318-001-01150 mL in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/24/2014

LABELER - DoctorAN(689060281)

REGISTRANT - DoctorAN(689060281)

Establishment
Name Address ID/FEI Business Operations
DoctorAN 689060281 manufacture(69318-001)

PRINCIPAL DISPLAY PANEL

AN12