Label: DRIPPN PURE NATURE HAND SANITIZER- ethyl alcohol 70% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80740-003-01, 80740-003-02, 80740-003-03, 80740-003-04, view more80740-003-05 - Packager: iGermx LLC
- 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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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:
- 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.
- 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%
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
DRIPPN PURE NATURE HAND SANITIZER
ethyl alcohol 70% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80740-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:80740-003-01 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2020 2 NDC:80740-003-02 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2020 3 NDC:80740-003-03 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2020 4 NDC:80740-003-04 236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2020 5 NDC:80740-003-05 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/01/2020 Labeler - iGermx LLC (117603473)