Label: AN12- allantoin, glycerin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69318-001-01, 69318-001-02 - Packager: DoctorAN
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 24, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- INSTRUCTIONS FOR USE
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INACTIVE INGREDIENT
Pure water, Butylene glycol, Anemarrhena asphodeloides bunge extract, Propylene glycol, Cetyl alcohol, Glyceryl stearate/PEG-100-Stearate, Betaine, Arbutin, Phytrogen, Sorbitan sesquioleate, Polysorbate 80, Sorbitan stearate, Macadamia ternifolia seed oil, Simmondsia chinensis seed oil, Dipotassium glycyrrhizate, Triethanolamine, 1,2-hexandediol, Adenosine, Carbomer, Tocopheryl acetate, Sodium hyaluronate, Cultured wild ginseng roots extracts, Rose extract, Soybean extract, Portulaca oleracea extract, Perfume
- PRINCIPAL DISPLAY PANEL
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
AN12
allantoin, glycerin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69318-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.3 mg in 150 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 3 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 1 NDC:69318-001-02 1 in 1 CARTON 10/24/2014 1 NDC:69318-001-01 150 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)
