Label: HAND SANITIZER- rawganic organic alcohol hand wipes swab

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 16, 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:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 62% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic.

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat, flame, sparks, electricals. Do no smoke, drink or inhale.

  • Do not use

    Do not use as baby wipes, or on children under 2 years old. On broken skin. Around the eyes - in case of eye contact, rinse eyes thoroughly with water. If irritation persists, seek medical advice.

  • WHEN USING

    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 consult a doctor if irritation or rash occurs. Keep out of reach of children.

  • STOP USE

    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

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

  • Directions

    Wipe hands thoroughly including between fingers & around fingernails. Allow to air dry. Dispose of after use.

  • Other information

    Store between 15°-25°C (59-77°F). Avoid excessive heat and direct sunlight. Once opened keep pack sealed.

  • Inactive ingredients

    Aqua, glycerin, Citrus Limon Peel Oil.

  • Package Label - Principal Display Panel

    25 alcohol wipes packet label25 wipes NDC: 79179-0738-1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    rawganic organic alcohol hand wipes swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79179-0738
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77.5 mL  in 125 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.25 mL  in 125 mL
    LEMON OIL (UNII: I9GRO824LL) 0.0625 mL  in 125 mL
    WATER (UNII: 059QF0KO0R) 46.249375 mL  in 125 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79179-0738-1125 mL in 1 PACKET; Type 0: Not a Combination Product12/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/07/2020
    Labeler - Pearmine Health Ltd (222365548)
    Registrant - Pearmine Health Ltd (222365548)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pearmine Health Ltd222365548manufacture(79179-0738)
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