VIVITAR ADVANCED HAND SANITIZER

Vivitar Advanced Hand Sanitizer by

Drug Labeling and Warnings

Vivitar Advanced Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sakar International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VIVITAR ADVANCED HAND SANITIZER- ethyl alcohol gel 
Sakar International, Inc.

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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VIVITAR ADVANCED HAND SANITIZER

Drug Facts

Active ingredient

Ethyl Alcohol 75% v/v

Purpose

Antimicrobial

Use:

Hand sanitizer to help reduce bacteria on skin.

Warnings:

Flammable. Keep away from fire or flame.

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and rash appears and lasts. 

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

Directions:

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using.

Other information:

Store below 110°F (43°C)

Inactive ingredients:

Water, Glycerol, Carbomer, Parfum, Aminomethylpropanol, Aloe, Vitamin E

improving LIVES

KILLS 99.99% OF GERMS

ANTIBACTERIAL FORMULA

PARABEN FREE

3x MOISTURIZING

SAVE YOURSELF

SAVE THE WORLD

With Aloe & Vitamin E

VIVITAR

© 2020 Sakar International

195 Carter Drive

Edison, NJ 08817

Support: 800 592 8541

www.vivitar.com

Made in China

Packaging

VIVITAR ADVANCED HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79821-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE (UNII: V5VD430YW9)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79821-001-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2020	03/28/2023
2	NDC: 79821-001-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2020	03/28/2023
3	NDC: 79821-001-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2020	03/28/2023
4	NDC: 79821-001-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2020	03/28/2023
5	NDC: 79821-001-03	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2020	03/28/2023
6	NDC: 79821-001-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2020	03/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/28/2020	03/28/2023

Labeler - Sakar International, Inc. (086413028)

Revised: 7/2021

Document Id: df33fc03-60fc-42c4-a4ac-3a1a4d7a60a6

34390-5

Set id: f440d260-6820-4bd8-98f5-7427b3105306

Version: 2

Effective Time: 20210729