Label: PURIFIED WATER- hyaluronic acid injection, solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 1, 2023

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  • Active Ingredients

    purified water

  • Purposes

    Purified Water------------Vaginal Irrigation

  • Uses

    Vaginal douche for disinfection. pH balance, and skin barrier. Relieves minor vaginal like itching or soreness.

  • Warnings

    Do not use the product to areas with scars, eczema, or dermatitis.

  • Warnings

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Warnings

    Stop use and ask a doctor if

    irritation, rash, red spot on the skin, or swelling occurs. These may be signs of a severe condition.

  • Warnings

    When using this product skin irritation and dryness is more likely to occur if you use
    another topical acne medication at the same time. If irritation occurs, only use one
    topical acne medication at a time.

  • Warnings

    This product is for external use only. Women during menstruation and pregnancy should not use it. Not suitable for children under 3 years of age.

  • Directions

    Use the product as a douche as needed.

  • Inactive Ingredients

    HYALURONIC ACID

  • Label

    LACTOMEDI Vaginal Irrigation

  • INGREDIENTS AND APPEARANCE
    PURIFIED WATER 
    hyaluronic acid injection, solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83490-315
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.99 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83490-315-0150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2023
    Labeler - 2359 US INC (118974080)
    Registrant - 2359 US INC (118974080)
    Establishment
    NameAddressID/FEIBusiness Operations
    isamogu Inc.695695834manufacture(83490-315)
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