Label: SANITIZER HAND AND SKIN CARE- silver chloride cream

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

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Drug Label Information

Updated February 12, 2021

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  • Active Ingredient

    Silver Chloride 0.3% w/w

  • Purpose

    Antiseptic

  • Uses

    To help reduce the number of disease-causing bacteria, virus, and fungi until the next hand wash.

    For use when soap and water are not available.

  • Warnings

    For external use only.

    Keep out of reach of children under 6 years of age.

    When using this product:

    • keep out of eyes, ears, and mouth.
    • Do not ingest.
    • In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

  • Directions

    • Apply after cleansing and drying the skin surface on hand or elsewhere.

    • Apply a generous amount and spread evenly to cover all surfaces.

    • Can be applied regularly.

  • Other information or comments

    • Store between 15-30 C (59-86 F)
    • Avoid freezing and excessive heat above 40 C (104 F).

  • Inactive Ingredients

    Water (Aqua), Stearic acid, Glycerin, Sodium bentonite, Phenoxyethanol, Acrylate copolymer, Triethanolamine, Caprylyl glycol, Titanium dioxide

  • Principal Display Panel

    Sanitizer Hand and Skin Care (50 mL), NDC: 81541-001-01

    Outer Package (Box)

    Sanitizer Hand and Skin Care

    Inner Package (Tube)

    Sanitizer Hand and Skin Care_Tube

  • INGREDIENTS AND APPEARANCE
    SANITIZER HAND AND SKIN CARE 
    silver chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81541-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER CHLORIDE (UNII: MWB0804EO7) (SILVER CATION - UNII:57N7B0K90A) SILVER CATION0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (UNII: E5024Y9FFQ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENTONITE (UNII: K1BPI94O04)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81541-001-011 in 1 BOX02/10/2021
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/10/2021
    Labeler - Immunetec Proof Ltd. (366839547)
    Registrant - Immunetec Proof Kft. (366839547)
    Establishment
    NameAddressID/FEIBusiness Operations
    Immunetec Proof Kft.366839547manufacture(81541-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kedo Eurocosmetics Kft.427068692manufacture(81541-001)
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