ANTIBACTERIAL HAND SANITIZER Ocean Breeze Scented

Vivitar ANTIBACTERIAL HAND SANITIZER Ocean Breeze Scented by

Drug Labeling and Warnings

Vivitar ANTIBACTERIAL HAND SANITIZER Ocean Breeze Scented by is a Otc medication manufactured, distributed, or labeled by Sakar International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VIVITAR ANTIBACTERIAL HAND SANITIZER OCEAN BREEZE SCENTED- 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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ANTIBACTERIAL HAND SANITIZER Ocean Breeze Scented

Drug Facts

Active Ingredient

Ethyl Alcohol 70% +/- 5%

Purpose

Antimicrobial Agent

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.

Stop use and ask a doctor if irritation or 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

Ocean Breeze Scented

KILLS 99.99% OF BACTERIA*

70% ETHYL ALCOHOL

VIVITAR®

© 2021 Sakar International

195 Carter Drive

Edison, NJ 08817

Support: 800 592 9541

www.vivitar.com

Made in China

*Escherichia Coli and Staphylococcus Aureus

Keep All Relevant Information for Future Reference.

*All brand, product names and logos are trademarks or registered trademarks of their respective companies.

Packaging

VIVITAR ANTIBACTERIAL HAND SANITIZER OCEAN BREEZE SCENTED 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79821-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.70 mL  in 1 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: 79821-006-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2021	09/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/2021	09/30/2023

Labeler - Sakar International, Inc. (086413028)

Revised: 7/2021

Document Id: 8cdaab89-bb40-4579-8a72-49bb78728adc

34390-5

Set id: 3ff8c9b8-411d-4dce-8ceb-a4c902520500

Version: 2

Effective Time: 20210729