FANCYCLEAN ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid
Fancyheat Corporation

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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FANCY CLEAN ANTISEPTIC HAND SANITIZER SPRAY

Drug Facts

Active ingredient

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

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

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

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

Directions

• wet hands thoroughly with product and allow to dry without wiping

• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)

• avoid freezing and excessive heat above 40°C (104°C)

Inactive ingredients

glycerin, hydrogen peroxide, water

Questions? +1-973-589-1450

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

ALCOHOL BASED

Made from ETHANOL

A RENEWABLE RESOURCE

NON TOXIC

ALCOHOL 80% ANTISEPTIC TOPICAL SOLUTION

NON-STERILE SOLUTION

UN1170 ETHANOL SOLUTIONS 3, PG III

Manufactured by: FANCYHEAT CORPORATION

40, VERONICA AVENUE, SOMERSET, NJ 08873

Lot no.:

Expiry:

www.FancyHeat.com

Packaging

untitled

FANCYCLEAN ANTISEPTIC HAND SANITIZER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73744-258
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L in 100 L

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73744-258-02	0.059 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/27/2020	05/13/2024
2	NDC:73744-258-01	3.78 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/27/2020	05/13/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/27/2020	05/13/2024

Labeler - Fancyheat Corporation (039553586)

Name	Address	ID/FEI	Business Operations
Establishment
Fancyheat Corporation		039553586	manufacture(73744-258)

Revised: 11/2021

Document Id: 3b0cda42-907a-46d3-a27f-1db0bbefa8b3

Set id: dca8e458-8e97-48e4-b629-889825965826

Version: 2

Effective Time: 20211122

Fancyheat Corporation