DermoViva Hydra Alcohol Hand Sanitizer Gel with Aloe

DermoViva Hydra-Alcohol Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

DERMOVIVA HYDRA-ALCOHOL HAND SANITIZER WITH ALOE- alcohol gel 
Dabur International Limited

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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DermoViva Hydra Alcohol Hand Sanitizer Gel with Aloe

Drug Facts

Active ingredient

Alcohol 70%

Purpose

Antiseptic

Uses

• to decreas bacteria on the skin
• recommended for repeated use

Warnings
For external use only.

Flammable. Keep away from fire or flame.

When using this product keep away from eyes. In case of eye contact with eyes, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally to hands to cover all surfaces
• rub hands together until dry.
• supervise children under 6 years old
• not recommended for infants

Other information

store between 15°-30°C (59°-86°F)

Inactive ingredients

water, glycerin, propylene glycol, triethanolamine, aloe barbadensis (Aloe Vera) leaf juice

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

DermoViva
HYDRA-ALCOHOL GEL HAND SANITIZER

with moisturizing Aloe
Contains 70% Alcohol

NDC: 75349-003-02
CLEANSE + PROTECT

16 fl. oz. (473 mL)

DERMOVIVA HYDRA-ALCOHOL HAND SANITIZER  WITH ALOE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75349-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75349-003-01	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/09/2020	05/31/2022
2	NDC: 75349-003-02	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/09/2020	05/31/2022
3	NDC: 75349-003-03	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/10/2020	05/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/09/2020	05/31/2022

Labeler - Dabur International Limited (851038067)

Revised: 7/2021

Document Id: c68f114d-e0eb-76a2-e053-2a95a90a9a9e

34390-5

Set id: a6b5cbb5-7f7b-4be0-e053-2995a90a7f88

Version: 3

Effective Time: 20210707