Label: DRIPPN PURE NATURE HAND SANITIZER- ethyl alcohol 70% 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 September 24, 2020

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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 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) (70%, 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. Glycerin 0.1854%
    3. Hydrogen peroxide (0.125% v/v).
    4. Water 36.95%
    5. Carbopol 0.824%
    6. Aloe Vera 0.515%
    7. Peppermint 0.215%
    8. AMP 0.1524%
    9. Menthol 0.0515%
    10. Blue 0.00824%

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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 or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • 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 ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    • 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.
  • Other information

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

    Glycerin 0.1854%
    Hydrogen peroxide (0.125% v/v).
    Water 36.95%
    Carbopol 0.824%
    Aloe Vera 0.515%
    Peppermint 0.215%
    AMP 0.1524%
    Menthol 0.0515%
    Blue 0.00824%

  • Package Label - Principal Display Panel

    80740-003-04 1 BOTTLE 236 ml

    80740-001-0r 1 BOTTLE 8 oz

    80740-003-01 1 BOTTLE 1 L

    80740-001-01 1 BOTTLE 1 L

    80740-003-02 1 BOTTLE 1 G

    80740-001-02 1 BOTTLE 1 G

    80740-003-03 1 BOTTLE 473 ml

    80740-001-03 1 BOTTLE 473ml

    80740-003-05 1 BOTTLE 59 ml

    80740-001-05 1 BOTTLE 59ml

  • INGREDIENTS AND APPEARANCE
    DRIPPN PURE NATURE HAND SANITIZER 
    ethyl alcohol 70% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80740-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.1854 mL  in 1 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 1 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.824 mL  in 1 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1524 mL  in 1 mL
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.215 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.37 mL  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) 0.0515 mL  in 1 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00824 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80740-003-011000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    2NDC:80740-003-023785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    3NDC:80740-003-03473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    4NDC:80740-003-04236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    5NDC:80740-003-0559 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2020
    Labeler - iGermx LLC (117603473)
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