Label: AN12 ANUS PREMIUM CLEANSER- glycerin, allantoin gel

  • 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 5, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Glycerin 3%

    Allantoin 0.1%

  • Purpose

    skin protectant

  • Warnings

    If you have symptoms such as red spots, swelling, itching, etc. stop using them and consult a specialist.

  • Warnings

    Do not use on areas with scars.

  • Warnings

    Keep it out of reach of children.

  • Inactive Ingredients

    Water, Cocamide DEA, Centella Asiatica Extract, Portulaca Oleracea Extract, Hamamelis Virginiana (Witch Hazel) Extract, PEG-40 Hydrogenated Castor Oil, Butylene Glycol, Artemisia Vulgaris Extract, Polysorbate 80, Oryza Sativa (Rice) Bran Extract, Phaseolus

    Radiatus Seed Extract, Eucalyptus Globulus Leaf Extract, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Lauryl Glucoside, Decyl Glucoside, Carica Papaya (Papaya) Leaf Extract,

    Houttuynia Cordata Extract, RH-Oligopeptide-1, Crataegus Oxyacantha Extract, Rheum Palmatum Root Extract, Bambusa Vulgaris Extract, Punica Granatum Fruit Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, 1,2-Hexanediol, Hydroxyethylcellulose,

    Fragrance, Citric Acid, Disodium EDTA, Royal Jelly, Propolis Extract, Ascorbic Acid, Menthol

  • Uses

    Maintaining anus cleanliness and neat condition.

    Removal of noxious material such as heavy metal and fluorescent material and protection of anus oil membrance without irritation.

  • Directions

    1. Wet your body and area around the anus with warm water.

    2. Pump 2~3 times and evenly apply it to the area around the anus and then, generate bubbles with massage.

    3. Gently massage with the remaining bubbles along external anus and the surrounding area and then, maintain for 30 seconds.

    4. Rinse to ensure that there is no residue left.

  • Warnings

    Do not use for other than intended purpose.

  • Pakage Label

    AN12_Display Panel

  • INGREDIENTS AND APPEARANCE
    AN12 ANUS PREMIUM CLEANSER 
    glycerin, allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82385-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 g  in 100 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    LACTUCA INDICA WHOLE (UNII: KF4TFR6V36)  
    DRABA NEMOROSA WHOLE (UNII: 8ELE55D80G)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MENTHOL (UNII: L7T10EIP3A)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    MUNG BEAN (UNII: 1LIB31N73G)  
    ROYAL JELLY (UNII: L497I37F0C)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    NEPIDERMIN (UNII: TZK30RF92W)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PURSLANE (UNII: M6S840WXG5)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    RICE BRAN (UNII: R60QEP13IC)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    CHENOPODIUM ALBUM FLOWER (UNII: 0W0371JRM3)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    CRATAEGUS LAEVIGATA WHOLE (UNII: EFX9G567MJ)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    CORYDALIS AMBIGUA WHOLE (UNII: 7W0K1TRS77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82385-102-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/19/2021
    Labeler - BESTVALUE Co., Ltd (694025785)