Label: BIOM SANITIZING ALCOHOL WIPES - BERGAMOT BLOOM- alcohol swab

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

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Drug Label Information

Updated October 12, 2023

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    - Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, volume/volume (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

  • Active Ingredient(s)

    Alcohol 65% w/w. Purpose: Antiseptic

  • Purpose

    Reducing bacteria on skin.

  • Directions

    Wipe hands thoroughly. Discard after use.

  • Warnings

    Flammable. Keep away from Fire and Flame. External Use Only. Do not use in eyes. If contact occurs, flush thoroughly with water. Stop use and ask doctor if redness or irritation develops and continues for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact the poison control center immediately.

  • STOP USE

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

  • Other information

    Store below 104° F (40° C).
    Each wipe is 15 x 20 cm.
    May discolor certain fabrics.
    Do not use as a baby wipe, on
    the face, or in the genital area.

  • Inactive ingredients

    Water, Citrus Bergamia Peel Oil (Bergamot Essential Oil), Aloe Barbadensis Leaf Juice (Organic Aloe), Glycerin (Moisturizer)

  • Keep out of reach of children

    If swallowed, get medical help or contact the poison control center immediately.

  • Dosage and Administration

    Ethanol 65%. Wipe hands thoroughly. Discard after use.


  • Package Label - Principal Display Panel

    50 wipes; NDC: 82311-0102-1

    BIOM02 Bergamot Bloom - sanitising alcohol wipes

  • INGREDIENTS AND APPEARANCE
    BIOM SANITIZING ALCOHOL WIPES - BERGAMOT BLOOM 
    alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82311-0102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL184.1 mL  in 263 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7) 0.1315 mL  in 263 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 2.63 mL  in 263 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2.64315 mL  in 263 mL
    WATER (UNII: 059QF0KO0R) 73.49535 mL  in 263 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82311-0102-1263 mL in 1 PACKAGE; Type 0: Not a Combination Product12/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/04/2021
    Labeler - Biom Innovations Inc (118335373)
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