HAND SANITIZER- ethyl alcohol gel 
CAPNA Fabrication

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)

Ethyl 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

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

Purified Water, Acrylates Copolymer, Glycerin, Aminomethylpropanol, Hydrogen Peroxide

Package Label - Principal Display Panel

The label image provided below,

CAPNA LABEL

pertains to the following packaging sizes and NDC codes:

2 Oz / 59 mL 77434-001-01

4 Oz / 118 mL 77434-001-02

6.4 Oz / 189 mL 77434-001-03

8 Oz / 236 mL 77434-001-04

11.8 Oz / 349 mL 77434-001-05

12.6 Oz / 375 mL 77434-001-06

16 Oz / 473 mL 77434-001-07

1 Gal / 3785 mL 77434-001-11

Package Label - Principal Display Panel

The label image provided below,

Capna Label 2

pertains to the following packaging sizes and NDC codes:

2 Oz / 59 mL 77434-002-01

4 Oz / 118 mL 77434-002-02

6.4 Oz / 189 mL 77434-002-03

8 Oz / 236 mL 77434-002-04

11.8 Oz / 349 mL 77434-002-05

12.6 Oz / 375 mL 77434-002-06

16 Oz / 473 mL 77434-002-07

1 Gal / 3785 mL 77434-002-11

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77434-002
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.2 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 7 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.42 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 21.255 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77434-002-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:77434-002-113780 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
3NDC:77434-002-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:77434-002-03189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:77434-002-04236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
6NDC:77434-002-05349 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
7NDC:77434-002-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
8NDC:77434-002-06375 mL in 1 BOTTLE, PLASTIC; 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
HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77434-001
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.2 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 7 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.42 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 11.255 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77434-001-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:77434-001-113780 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
3NDC:77434-001-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:77434-001-03189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:77434-001-04236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
6NDC:77434-001-05349 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
7NDC:77434-001-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
8NDC:77434-001-06375 mL in 1 BOTTLE, PLASTIC; 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 - CAPNA Fabrication (019040504)
Registrant - CAPNA Fabrication (019040504)
Establishment
NameAddressID/FEIBusiness Operations
CAPNA Fabrication019040504manufacture(77434-001, 77434-002)

Revised: 9/2020
Document Id: 6a3bdd80-0e2f-4170-89ea-76de393df7a4
Set id: a447b9db-d227-2fe3-e053-2995a90a5add
Version: 4
Effective Time: 20200915
 
CAPNA Fabrication