HAND SANITIZER- alcohol gel 
Magaña Muela, Jesús

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

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, 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.

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

Distillet water, glycerin, carbomer 940, Trolamine

Package Label - Principal Display Panel

Label 3785 mL Gel3785 mL NDC 77934-123-11

Package Label - Principal Display Panel

Label 125 mL Gel125 mL NDC 77934-123-07

Package Label - Principal Display Panel

Label 250 mL Gel250 mL NDC 77934-123-08

Package Label - Principal Display Panel

Label 946 mL Gel946 mL NDC 77934-123-09

Package Label - Principal Display Panel

Label 1893 mL Gel1893 mL NDC 777934-123-10

Pachage Label - Principal Display Panel

Label 20000 mL Gel20000 mL NDC 77934-123-13

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77934-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E) 0.6 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.8 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 18 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77934-123-07125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2020
2NDC:77934-123-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2020
3NDC:77934-123-09946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2020
4NDC:77934-123-101893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2020
5NDC:77934-123-113785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2020
6NDC:77934-123-1320000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product05/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/16/2020
Labeler - Magaña Muela, Jesús (951577940)
Registrant - Mario Hidalgo (080666336)
Establishment
NameAddressID/FEIBusiness Operations
Magaña Muela, Jesús951577940manufacture(77934-123)

Revised: 5/2020
Document Id: a5cca49b-7f52-1f54-e053-2a95a90aff53
Set id: a5cca49b-7f60-1f54-e053-2a95a90aff53
Version: 1
Effective Time: 20200516
 
Magaña Muela, Jesús