Label: ACMEROS LUBRICANT X0026F3541- personal lubricant oil

  • 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 November 23, 2020

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

  • Active ingredient

    butylene glycol (20%): 47.2g(mL)/package

  • Inactive ingredient

    Inactive ingredient:

    water (67.52%): 159.3472mL/package

    aloe extract (10%): 23.6mL/package

    hydroxyethylcellulose (1.6%): 3.776mL/package

    polyethylene glycol 300000 (0.5%): 1.18mL/package

    phenoxyethanol (0.3%): 0.708mL/package

    chlorphenesin (0.08%): 0.1888mL/package

  • Purpose

    This lubricant is made from high quality raw materials.

    It can achieve higher lubricantion, longer lubrication time and less dosage.

  • When using

    Virginal dryness and/or intimate sexual activity.

  • Do not use

    Do not use when wound or skin infection.

  • Stop use

    If irritation or discomfort occurs, discontinue use and see a doctor.

    Very slippery on surfaces, clean spills immediately.

  • Ask doctor

    If irritation or discomfort occurs, discontinue use and see a doctor.

  • Ask doctor/pharmacist

    Ask doctor/pharmacist when you current use other drugs.

  • Keep out of reach of children

    Keep out of reach of children and pets.

  • Questions

    Please contact us when you have any questions.

  • Pregnancy or breast feeding

    Pregnant or breast feeding women shall follow doctor advice.

  • Indications & usage

    This product is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity, help relieve virginal dryness, and supplement to the body's natural lubricant.

    Apply a small amount to genital areas. Reapply as needed or desired.

  • Dosage & administration

    One bottle of 236mL in one bottle/package.

    Apply a small amount to the area of the body you wish to lubricate.

  • Dosage forms & strengths

    The lubricant is like oil form. Strengths: 20%.

    A small amount one time, or reapply as needed or desired.

  • Warnings

    If irritation or discomfort occurs, discontinue use and see a doctor.
    This is not a contraceptive or spermicide.

    Keep out of reach of children and pets.
    Keep out of eyes and ears.

  • Package label. Principal display panel

    Container

    Container

    Package

    Package

  • INGREDIENTS AND APPEARANCE
    ACMEROS LUBRICANT X0026F3541 
    personal lubricant oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73194-212
    Route of AdministrationCUTANEOUS, EXTRACORPOREAL, VAGINAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) BUTYLENE GLYCOL47.2 g  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOIN (UNII: W41H6S09F4) 23.6 mL  in 236 mL
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E) 3.776 mL  in 236 mL
    WATER (UNII: 059QF0KO0R) 159.3472 mL  in 236 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.708 mL  in 236 mL
    POLYETHYLENE GLYCOL 300000 (UNII: 4QIB4U4CQR) 1.18 mL  in 236 mL
    CHLORPHENESIN (UNII: I670DAL4SZ) 0.1888 mL  in 236 mL
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73194-212-61236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/25/2019
    Labeler - Shenzhen Yuqintang Shengwu Jishu Co., Ltd. (419298167)
    Registrant - Shenzhen Yuqintang Shengwu Jishu Co., Ltd. (419298167)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Yuqintang Shengwu Jishu Co., Ltd.419298167label(73194-212)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongguan Chunzhen Biological Technology Co.,Ltd554420621manufacture(73194-212)