Bonafide Innovations Hand Sanitizer Gallon Jug

Bonafide Innovations Gel Hand Sanitizer by

Drug Labeling and Warnings

Bonafide Innovations Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Bonafide Innovations LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BONAFIDE INNOVATIONS GEL HAND SANITIZER- alcohol gel 
Bonafide Innovations 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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Bonafide Innovations Hand Sanitizer Gallon Jug

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 75% 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 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

  • 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

aloe vera, aminomethyl propanol, carbomer, fragrance, glycerin, panthenol, propylene glycol, purified water USP, tocoheryl acetate

Package Label - Principal Display Panel

Bonafide innovations Gel Hand Sanitizer3.79 L NDC: 71849-100-01

BONAFIDE INNOVATIONS GEL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71849-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2.38 kg  in 3.79 L
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.00038 kg  in 3.79 L
WATER (UNII: 059QF0KO0R) 0.878 kg  in 3.79 L
ISOPROPYL ALCOHOL (UNII: ND2M416302) 0.119 kg  in 3.79 L
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0000379 kg  in 3.79 L
GLYCERIN (UNII: PDC6A3C0OX) 0.019 kg  in 3.79 L
CARBOMER 940 (UNII: 4Q93RCW27E) 0.0095 kg  in 3.79 L
PANTHENOL (UNII: WV9CM0O67Z) 0.002 kg  in 3.79 L
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.019 kg  in 3.79 L
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.025 kg  in 3.79 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71849-100-013.79 L in 1 JUG; Type 0: Not a Combination Product10/30/202012/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/30/202012/01/2022
Labeler - Bonafide Innovations LLC (016579579)
Registrant - Bonafide Innovations LLC (016579579)
Establishment
NameAddressID/FEIBusiness Operations
Bonafide Innovations LLC016579579manufacture(71849-100)

Revised: 1/2023
Document Id: f32d243d-ff77-3fa3-e053-2995a90a8180
Set id: b2c3c392-4c58-366e-e053-2995a90a67e2
Version: 3
Effective Time: 20230126