Label: WATER-BASED PERSONAL LUBRICANT, ACVIOO 001- 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 May 7, 2018

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

  • Active ingredient

    butylene glycol (20%): 80g/package or 80mL/package

  • Inactive ingredient

    Inactive ingredient:

    water (77.52%): 310.08mL/package

    hydroxyethylcellulose (1.6%): 6.4mL/package

    polyethylene glycol 300000 (0.5%): 2mL/package

    phenoxyethanol (0.3%): 1.2mL/package

    chlorphenesin (0.08%): 0.32mL/package

  • Purpose

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

    This product is not a contraceptive and does not contain a spermicide.

  • When using

    Virginal dryness and/or intimate sexual activity.

    This product is not a contraceptive and does not contain a spermicide.

  • Do not use

    Do not use when wound or skin infection.

    It should be cautiously used if you are kind of allergic constitution or you have inflammation.
    Do not use if quality seal on the opening of the tube is broken or missing.
    Do not use if tamper-evident seal is removed or broken.

  • Stop use

    If irritation or discomfort occurs, discontinue the use and consult a physician.
    Very slippery on surfaces, clean spills immediately.

  • Ask doctor

    If irritation or discomfort occurs, discontinue the use and consult a physician.

  • 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 away from eyes and ears.

  • Questions

    Please contact us when you have any questions.

  • Pregnancy or breast feeding

    Pregnant or breast feeding women shall follow doctor advice.

  • Indications & usage

    ACVIOO 001 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 400mL in one package.

  • Dosage forms & strengths

    The lubricant is like oil form.

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

    The active ingredient strength is 20%.

  • Warnings

    If irritation or discomfort occurs, discontinue the use and consult a physician.
    Very slippery on surfaces, clean spills immediately.

    This product is not a contraceptive and does not contain a spermicide.

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  • INGREDIENTS AND APPEARANCE
    WATER-BASED PERSONAL LUBRICANT, ACVIOO 001 
    personal lubricant oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71847-2215
    Route of AdministrationCUTANEOUS, EXTRACORPOREAL, VAGINAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) BUTYLENE GLYCOL80 g  in 400 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E) 6.4 mL  in 400 mL
    WATER (UNII: 059QF0KO0R) 310.08 mL  in 400 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 1.2 mL  in 400 mL
    POLYETHYLENE GLYCOL 300000 (UNII: 4QIB4U4CQR) 2 mL  in 400 mL
    CHLORPHENESIN (UNII: I670DAL4SZ) 0.32 mL  in 400 mL
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71847-2215-7400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/07/2018
    Labeler - Shenzhen Dikailong Technology Ltd (544556869)
    Registrant - Shenzhen Dikailong Technology Ltd (544556869)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Dikailong Technology Ltd544556869label(71847-2215) , manufacture(71847-2215)