79740-003 Vertra Hand Sanitizer topical solution

Vertra Hand Sanitizer topical solution by

Drug Labeling and Warnings

Vertra Hand Sanitizer topical solution by is a Otc medication manufactured, distributed, or labeled by ANTHOS GROUP, INC, THE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VERTRA HAND SANITIZER TOPICAL SOLUTION- hand sanitizer topical solution liquid 
ANTHOS GROUP, INC, THE

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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79740-003
Vertra Hand Sanitizer topical solution

Active Ingredient(s)

Alcohol 80% v/v

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

in children less than 2 months of age
on open skin wounds

Stop use and ask a doctor if irritation or rash occurs.
These may be signs of a serious condition

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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
Superise children under 6 years of age when usingproduct to avoid swallowing.

Other information

Store between 15-20C(59-86F)
Acoid freezing and excessive hear about 40C(104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

VERTRA HAND SANITIZER TOPICAL SOLUTION 
hand sanitizer topical solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79740-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79740-003-10	1920 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
2	NDC: 79740-003-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
3	NDC: 79740-003-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
4	NDC: 79740-003-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
5	NDC: 79740-003-05	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
6	NDC: 79740-003-06	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
7	NDC: 79740-003-07	360 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
8	NDC: 79740-003-08	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
9	NDC: 79740-003-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022
10	NDC: 79740-003-09	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	11/14/2022

Labeler - ANTHOS GROUP, INC, THE (117511051)

Establishment
Name	Address	ID/FEI	Business Operations
ANTHOS GROUP, INC, THE		117511051	manufacture(79740-003)

Revised: 11/2022

Document Id: ed6d784d-9e01-c4d9-e053-2a95a90a6734

34390-5

Set id: abb9e99c-1169-176c-e053-2a95a90a31cd

Version: 3

Effective Time: 20221114