HAND SANITIZER- alcohol gel 
Diquisa, S.A. de C.V

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 Gel

The hand sanitizer gel is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product.

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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 (0.2% v/v).
  3. Trolamine (0.15% v/v).
    d. Carbomer (0.3 % )
    e. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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.

Inactive ingredients

glycerin, trolamine, carbomer, streriled or distilled water

Other information

Directions

Package Label - Principal Display Panel

Hand Sanitizer 1 Gallon 1 gallon NDC: 78361-002-04



1000 ml label

1000 ml NDC 78361-002-06

500 ml label500 ml NDC 78361-002-07


250 ml label 250 ml NDC 78361-002-08


60 ml label60 ml NDC 78361-002-09

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78361-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.4 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78361-002-053780 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78361-002-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78361-002-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78361-002-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:78361-002-0960 mL in 1 BOTTLE; 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 - Diquisa, S.A. de C.V (815736509)
Establishment
NameAddressID/FEIBusiness Operations
Diquisa, S.A. de C.V.815736509manufacture(78361-002)

Revised: 6/2020
Document Id: a75d586d-2f2c-f796-e053-2995a90ac776
Set id: a67e63dc-0115-1834-e053-2995a90a4d40
Version: 3
Effective Time: 20200605
 
Diquisa, S.A. de C.V