DERMOVIVA HAND SANITIZER- alcohol solution

DermoViva Hand Sanitizer by

Drug Labeling and Warnings

DermoViva Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dabur International Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Alcohol 80% v/v

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

Warnings
For external use only.

Flammable. Keep away from fire or flame.

Do not use

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

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.

DOSAGE & ADMINISTRATION

Directions

• place enough product on hands to cover all surfaces
• rub hands together until dry.
• supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING

Other information

• store between 15°-30°C (59°-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

* As per Laboratory study report

Mfd. for Dabur International Ltd, Jebel Ali Free zone,

Street No. N406, P.O. Box: 16944, Dubai, U.A.E.

Country of Origin: United Arab Emirates.

For adverse event reporting: Dabur International Ltd.

5 Independence Way - Suite 300 / Office # 46 & 50

Princeton, NJ 08540, Telephone: 609-514-5100

PRINCIPAL DISPLAY PANEL

DermoViva
Antibacterial HAND SANITIZER

Alcohol Antiseptic 80% Topical Solution
Non-sterile Solution

NDC: 75349-001-02
KILLS 99.9% GERMS*

16 fl. oz. (473 mL)

INGREDIENTS AND APPEARANCE

DERMOVIVA HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75349-001
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: 75349-001-01	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020
2	NDC: 75349-001-02	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/17/2020

Labeler - Dabur International Limited (851038067)