Label: SILVER BEAR DISTILLERY HAND SANITIZER liquid

  • 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 March 26, 2020

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  • Active Ingredient & back label

    Active Ingredient(s)

    Alcohol 80%v/v.....Antiseptic

    Back Label

  • Use(s) Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap aand water are not availeble

    Use(s)
    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap aand water
    are not availeble

    ;kefewfk

  • Warnings

    Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Warnings

  • Do not use • In children less than 2 months of age ​• On open skin wounds

    Do not use

  • When Using this product keep out of eyes, ears an mouth. In case of contact with eyes, rinse eyes thouroghly with water.

    When using

  • ASK DOCTOR

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

    Stop use

  • Keep Out of reach of children.

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

    Keep out of reach

  • INSTRUCTIONS FOR USE

    Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing.

    Instructions for use

  • OTHER SAFETY INFORMATION

    Other information

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

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

    other safety information

  • INACTIVE INGREDIENT

    Inactive ingredients Glycerin, hydrogen peroxide, purified water

    Inactive ingredients

  • DOSAGE & ADMINISTRATION

    TOPICAL SOLUTION

    topical solution

  • WARNINGS

    For external use only

    Not safe for consumption

    Warning

  • INDICATIONS & USAGE

    TOPICAL SOLUTION hAND SANITIZER

    For external use only

    Indications and usage

  • PRINCIPAL DISPLAY PANEL

    ALCOHOL ANTICEPTIC 80%

    TOPICAL SOLUTION HAND SANITIZER

    Silver Bear Distillery

    For external use only

    Not safe for consumption

    473ml 16oz Non-sterile Solution

    NDC74018-0001-1

    front label

  • INGREDIENTS AND APPEARANCE
    SILVER BEAR DISTILLERY HAND SANITIZER 
    silver bear distillery hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74018-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL141.6 mL  in 177 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 2.57 mL  in 177 mL
    WATER (UNII: 059QF0KO0R) 32.6 mL  in 177 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.23 mL  in 177 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74018-0001-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
    2NDC:74018-0001-2355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2020
    3NDC:74018-0001-3473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2020
    4NDC:74018-0001-4355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
    5NDC:74018-0001-5375 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/31/2020
    6NDC:74018-0001-6750 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/31/2020
    7NDC:74018-0001-7237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
    8NDC:74018-0001-8946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/31/2020
    Labeler - Siver Bear Distillery (084260134)
    Establishment
    NameAddressID/FEIBusiness Operations
    Silver Bear Distillery084260134manufacture(74018-0001)
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