Label: UTIMI WATER BASED PERSONAL LUBRICANT- personal lubricant lotion

  • 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 March 27, 2019

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

  • Active ingredient

    Hydroxyethyl Cellulose

  • Inactive ingredient

    De-lonized Water
    Glycerin
    Propylene Glycol
    Sodium Benzoate
    Polysorbate 20
    Disodium EDTA
    Lactic Acid

  • Purpose

    Utimi Personal Lubricant is a water-based lubricant for penile or vaginal application, intended to moisturize and enhance the ease and comfort of intimate sexual activity as well as supplement for the body's natural lubrication.

    This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

  • When using

    Virginal / Anal 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 container 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

    This is a water-based lubricant for penile or vaginal application, intended to moisturize and enhance the ease and comfort of intimate sexual activity as well as supplement for the body's natural lubrication.

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

  • Dosage & administration

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

  • Dosage forms & strengths

    The lubricant is like oil form.

    One capsule (0.9g lubricant and 0.3g gelatin coated) once time.

    The active ingredient strength is 0.324g.

  • Warnings

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

    Very slippery surfaces, clean the spills immediately.

    This product is not a contraceptive or spermicide.

    Keep out of children and pets' reach.

  • Package label. Principal display panel

    As attached.

    Container Label_Utimi

  • INGREDIENTS AND APPEARANCE
    UTIMI WATER BASED PERSONAL LUBRICANT 
    personal lubricant lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73000-225
    Route of AdministrationVAGINAL, RECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) (HYDROXYETHYL CELLULOSE (140 CPS AT 5%) - UNII:8136Y38GY5) HYDROXYETHYL CELLULOSE (140 CPS AT 5%)0.381 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.027 mL  in 30 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.3 mL  in 30 mL
    WATER (UNII: 059QF0KO0R) 25.008 mL  in 30 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.075 mL  in 30 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2.538 mL  in 30 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.665 mL  in 30 mL
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4) 0.006 mL  in 30 mL
    Product Characteristics
    ColorwhiteScoreno score
    ShapeFREEFORMSize50mm
    FlavorEGG NOGImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73000-225-2030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/27/2019
    Labeler - Shenzhen ZhiHuiChuangXiang Technology Co., Ltd (550748186)
    Registrant - Shenzhen ZhiHuiChuangXiang Technology Co., Ltd (550748186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen ZhiHuiChuangXiang Technology Co., Ltd550748186manufacture(73000-225) , label(73000-225)