Hand Sanitizer by Bluefin International Inc Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Bluefin 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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Hand Sanitizer

DRUG FACTS

Active Ingredients

Ethyl Alcohol 80%

Purpose

Antiseptic

Use[s]:

Use hand sanitizer to help reduce bacteria on the 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 or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply palmful to hands
• rub hands together vigorously until dry
• supervise children in the use of this product

Other Information

• Store below 110°F(43° C)
• may discolor certain fabrics or surfaces

Inactive Ingredients

Glycerin, Hydrogen Peroxide, Methylcellulose, Purified Water USP.

Package Labeling: 120ml

Package Labeling: 236ml

Package Labeling: 3785ml

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75295-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75295-001-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020	12/31/2021
2	NDC: 75295-001-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020	12/31/2021
3	NDC: 75295-001-12	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/20/2020	12/31/2021

Labeler - Bluefin International Inc (123176543)

Revised: 12/2021

Document Id: d3353f73-6bc3-6e77-e053-2a95a90a1737

34390-5

Set id: a85c1736-89db-8c6a-e053-2995a90ab8d4

Version: 2

Effective Time: 20211215