HAND SANITIZER B2- alcohol solution 
Global Impact Innovation 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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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 80% 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, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

HSB2Label

208 L NDC: 74588-535-01

HSB2275GLabel1040 L NDC: 74588-535-02

HSB2330GLabel1248 L NDC: 74588-535-03

HSB21GLabel3.785 L NDC: 74588-535-04

HSB25G

18.927 L NDC: 74588-535-05

HAND SANITIZER B2 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74588-535
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL168.11466 L  in 208 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 3.06548 L  in 208 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.25236 L  in 208 L
WATER (UNII: 059QF0KO0R) 33.42078 L  in 208 L
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 0.00067 L  in 208 L
FUSEL OIL (UNII: 2NK7O363Q6) 3.14615 L  in 208 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74588-535-01208 L in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:74588-535-021040 L in 1 TANK; Type 0: Not a Combination Product03/30/2020
3NDC:74588-535-031248 L in 1 TANK; Type 0: Not a Combination Product03/30/2020
4NDC:74588-535-043.785 L in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:74588-535-0518.927 L in 1 DRUM; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Global Impact Innovation LLC (117465830)
Registrant - Global Impact Innovation LLC (117465830)
Establishment
NameAddressID/FEIBusiness Operations
Global Impact Innovation LLC117465830manufacture(74588-535)

Revised: 4/2020
Document Id: a3450a60-fde7-9e26-e053-2a95a90a4528
Set id: a280e96a-2c72-6bf3-e053-2a95a90ad19f
Version: 3
Effective Time: 20200414
 
Global Impact Innovation LLC