HAND SANITIZER- isopropyl alcohol liquid 
Uncle Jumbo’s Distillery,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. 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.

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

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

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.

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.

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.

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

250 ML front Label250 ML Back Label250 mL NDC: 75526-000-00

354 ML Front Label354 ML Back Labe354 ML 75526-000-02

3890 ML label

3890 ML 75526-000-01

175frnt175bk1750ml 1.75 L front & Back

200mlbk200mlfrnt200 ml back & Frnt

473frnt473bk473 ml Front & Back

946bck946front946352 ml front & back

HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75526-000
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:75526-000-00250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:75526-000-013890 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
3NDC:75526-000-02354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:75526-000-03200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:75526-000-04946352 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
6NDC:75526-000-05473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
7NDC:75526-000-061750 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; 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 - Uncle Jumbo’s Distillery,Inc (090743531)
Establishment
NameAddressID/FEIBusiness Operations
Uncle Jumbo’s Distillery Inc090743531manufacture(75526-000)

Revised: 5/2020
Document Id: a4a06e2f-5775-4426-e053-2a95a90af603
Set id: a360ab33-3f90-50e9-e053-2995a90acb96
Version: 2
Effective Time: 20200501
 
Uncle Jumbo’s Distillery,Inc