Label: PERSONAL LUBRICANT- sodium hyaluronate gel

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 20, 2021

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  • SPL UNCLASSIFIED SECTION

    PERSONAL LUBRICANT

  • Active Ingredient(s)

    SODIUM HYALURONATE 0.01g/100mL

  • Purpose

    BACTERIOSTATIC

  • Use

    Uses for adult sexual wellness, which can produce lubrication to facilisexual activity.

  • Warnings

    This product cannot be used as spermicide or contraceptives.

    Please keep this product out of the reach of children.

    Discontinue use should any allergy occur.

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Squeeze out the product and apply desired amount onto the intimate area. Reapply as desired. It can be used for vaginal sex, oral sex, anal sex, etc.
  • Other information

    • Keep in sealed container, and place in a cool dry place.
  • Inactive ingredients

    WATER, GLYCEROL, PROPYLENE GLYCOL, CELLULOSE, SODIUM HYALURONATE, ETHYL 2-HYDROXYBENZOATE, ALOE SERUM.

  • Package Label - Principal Display Panel

    123

  • INGREDIENTS AND APPEARANCE
    PERSONAL LUBRICANT 
    sodium hyaluronate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81615-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ETHYL SALICYLATE (UNII: 555U6TZ2MV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81615-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2021
    2NDC:81615-001-0280 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2021
    3NDC:81615-001-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/16/2021
    Labeler - Jiangxi Renhetang pharmaceutical chain Co., Ltd. (410551226)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Kangmei medical and Health Products Co., Ltd528118770manufacture(81615-001)
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