Label: SILVER ION ANTIBACTERIAL GEL gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 2, 2021

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  • Main Active Ingredients and Content

    Silver ions, 0.05%.

    Glycerol, 5%.

  • Purpose

    Antibacterial

  • Scope of Use

    The product is suitable for antibacterial skin surface

  • Directions

    After cleaning the skin surface, apply it directly to the skin surface for 5minandletitdry naturally without washing after use.

  • Warning

    The product has antibacterial effect on staphylococcus aureus, escherichia coli and candida albicans.

  • Other Tips

    Place away from light, seal and store at room temperature.

  • Precautions

    See instructions for details

  • other ingredients

    Carbomer, PEG 400, Sodium Hydroxide, Purified Water etc.

  • WHEN USING

    See instructions for details

  • STOP USE

    See instructions for details

  • KEEP OUT OF REACH OF CHILDREN

    See instructions for details

  • Package Label - Principal Display Panel

    75139-007-01 3G

    75139-007-01 3G75139-007-02 5G

    75139-007-02 5G75139-007-03 10G

    75139-007-03 10G75139-007-04 20

    75139-007-04 2075139-007-05 30G

    75139-007-05 30G

  • INGREDIENTS AND APPEARANCE
    SILVER ION ANTIBACTERIAL GEL 
    silver ion antibacterial gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75139-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 g
    SILVER CATION (UNII: 57N7B0K90A) (SILVER CATION - UNII:57N7B0K90A) SILVER CATION0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75139-007-025 g in 1 BOTTLE; Type 0: Not a Combination Product04/28/2020
    2NDC:75139-007-013 g in 1 BOTTLE; Type 0: Not a Combination Product04/28/2020
    3NDC:75139-007-0530 g in 1 BOTTLE; Type 0: Not a Combination Product04/28/2020
    4NDC:75139-007-0420 g in 1 BOTTLE; Type 0: Not a Combination Product04/28/2020
    5NDC:75139-007-0310 g in 1 BOTTLE; Type 0: Not a Combination Product04/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/28/2020
    Labeler - Anson Bio-Technology Co.,Ltd. (547087171)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anson Bio-Technology Co.,Ltd.547087171manufacture(75139-007)
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