Label: GOUT- gout ointment ointment

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated July 6, 2022

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  • Active Ingredient(s)

    Chlorhexidine Acetate 0.3%

  • Purpose

    Skin Antibacterial

  • Use

    Inhibitory effect on Staphylococcus aureus, Escherichia coli, Candida albicans For external use only.

  • Do not use

    Pregnant women and those allergic to this product are prohibitedon open on open skin wounds

  • WHEN USING SECTION

    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

  • OTC - STOP USE SECTION

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

  • OTC - KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Place enough product on hands to cover all surfaces. Massage to absorb Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    [STORÁGE AND HANDLING SECTION]EDIT

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    Purified water, Cauliflower, Menthol, Myrrh

  • Warnings

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

  • Package Label - Principal Display Panel

    82877-001-0182877-001-0282877-001-0382877-001-04

  • INGREDIENTS AND APPEARANCE
    GOUT 
    gout ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82877-001
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE0.03 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAULIFLOWER (UNII: 138LUT2DWV)  
    MENTHOL (UNII: L7T10EIP3A)  
    MYRRH (UNII: JC71GJ1F3L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82877-001-0120 g in 1 BOX; Type 0: Not a Combination Product07/07/2022
    2NDC:82877-001-0230 g in 1 BOX; Type 0: Not a Combination Product07/07/2022
    3NDC:82877-001-0350 g in 1 BOX; Type 0: Not a Combination Product07/07/2022
    4NDC:82877-001-04100 g in 1 BOX; Type 0: Not a Combination Product07/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/07/2022
    Labeler - Shenzhen Boceda New Technology Co., Ltd. (616634883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Boceda New Technology Co., Ltd.616634883manufacture(82877-001)
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