HAND SANITIZER- isopropyl alcohol liquid 
NOORANI TRADING 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, rednedd or rash occurs. These may be signs of a serious condition.

Keep away from Children & pets.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

70 ml NDC: 77320-786-70

70 ml LABEL70 ml NDC: 77320-786-70

70 ml BOTTLE FRONT

70 ml BOTTLE FRONT70 ml NDC: 77320-786-70

70 ml BOTTLE BACK

70ml BOTTLE BACK70 ml NDC: 77320-786-70

540 ml LABEL

540 ml LABEL540 ML NDC: 77320-786-18

540 ml BOTTLE FRONT

540 ml BOTTLE FRONT540 ml NDC: 77320-786-18

540 ml BOTTLE BACK

540 ml BOTTLE BACK540 ml NDC: 77320-786-18

3840 ml LABEL

3840 ml LABEL3840 ml NDC: 77320-786-01

3840 ml GALLON FRONT

3840 ml GALLON FRONT3840 ml NDC: 77320-786-01

3840 ml GALLON BACK

3840 ml GALLON BACK3840 ml NDC : 77320-786-01

HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77320-786
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:77320-786-7070 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
2NDC:77320-786-013840 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
3NDC:77320-786-18540 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/15/2020
Labeler - NOORANI TRADING INC. (360658905)
Establishment
NameAddressID/FEIBusiness Operations
NOORANI TRADING INC360658905repack(77320-786)

Revised: 5/2020
Document Id: a5614f5a-32a3-0b1e-e053-2995a90a0243
Set id: a5615d8b-8836-39b1-e053-2a95a90af214
Version: 1
Effective Time: 20200515
 
NOORANI TRADING INC.