DRIPPN PURE NATURE HAND SANITIZER- ethyl alcohol 70% gel 
iGermx LLC

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.

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Hand Sanitizer

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

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 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.

Directions

Other information

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

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)

Revised: 9/2020
Document Id: b00c052b-a53b-6de2-e053-2a95a90a6325
Set id: b00c07ea-df43-9cab-e053-2a95a90ac72f
Version: 1
Effective Time: 20200924
 
iGermx LLC