HAND SANITIZER- isopropyl alcohol liquid 
Hobo Inc

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 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. Isopropyl Alcohol (75%, 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)

Isopropyl 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

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

3785 ml NDC: 74111-200-01 3785 mL Label

18925 ml NDC: 74111-200-05 18925 mL Label

475 ml NDC: 74111-200-16 475 mL Label

9460 ml NDC: 74111-200-25 9460 mL Label

946 ml NDC: 74111-200-32 946 mL Label

208175 ml NDC: 74111-200-55 208175 mL Label

HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74111-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74111-200-013785 mL in 1 JUG; Type 0: Not a Combination Product03/31/2020
2NDC:74111-200-0518925 mL in 1 PAIL; Type 0: Not a Combination Product03/31/2020
3NDC:74111-200-16475 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
4NDC:74111-200-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
5NDC:74111-200-259460 mL in 1 JUG; Type 0: Not a Combination Product03/31/2020
6NDC:74111-200-55208175 mL in 1 DRUM; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2020
Labeler - Hobo Inc (944358548)
Establishment
NameAddressID/FEIBusiness Operations
Hobo Inc944358548manufacture(74111-200)

Revised: 1/2022
Document Id: d5cbc90c-7ba9-0f87-e053-2995a90afaf4
Set id: a22bee59-b8a9-48db-e053-2a95a90a25aa
Version: 3
Effective Time: 20220117
 
Hobo Inc