HAND SANITIZER- alcohol liquid 
Iron Vault Distillery

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

  • 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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

89 mL Label750ml Back Label750 mL Front Label237 mL Label177 mL Label50 mL Label80mL Label

1 Gallon Front Label

1 Gallon Label Back

100 mL Label

118 mL Label

050 mL NDC:74206-001-01 See image 50 mL Label.jpg

177 mL NDC: 74206-001-02 See imgage 177 mL Label.jpg

237 mL NDC:74206-001-03 See image 237 mL Label.jpg

750 mL NDC:74206-001-04 See image 750 mL Front.jpg and 750mL Back - Drug Fact.jpg

080 mL NDC:74206-001-06 See image 80 mL Label.jpg

3785 mL NDC:74206-001-05 See image 1 Gallon Label Front.jpg and 1 Gallon Label Back.jpg

089 mL NDC:74206-001-07 See image 89 mL Label.jpg

100 mL NDC:74206-001-08 See image 100 mL Label.jpg

118 mL NDC:74206-001-09 See image 118 mL Label.jpg

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74206-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 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:74206-001-01177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:74206-001-0250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
3NDC:74206-001-03750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:74206-001-04237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:74206-001-053785 mL in 1 JUG; Type 0: Not a Combination Product05/14/2020
6NDC:74206-001-0680 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2020
7NDC:74206-001-0789 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2020
8NDC:74206-001-08100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2020
9NDC:74206-001-09118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202012/31/2021
Labeler - Iron Vault Distillery (097005232)
Establishment
NameAddressID/FEIBusiness Operations
Iron Vault Distillery097005232manufacture(74206-001)

Revised: 1/2022
 
Iron Vault Distillery