sparoom On The Go Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Unitrex Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol spray 
Unitrex Ltd.

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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sparoom On The Go Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 62% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire or flame.

Do not use

Do not use

• In children less than 2 months of age
• On open skin wounds

When using this product

When using this product Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use

Stop use and ask a doctor if irritation or rash occurs, these may be signs of a serious condition.

Keep out of reach of children

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

Aloe barbadensis leaf extract, glycerin, sterile distilled water, lemon fragrance

Other information

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

sparoom

ON THE GO

HAND SANITIZER

Kills 99.99% of Common Germs

Made with Aloe and Essential Oil

3 - 0.50 fl oz (15 mL) Sanitizers

Distributed by Unitrex Ltd. / SpaRoom
5060 Taylor Rd, Cleveland OH 44128

©2020 Unitrex

Questions? Toll-Free 1-833-729-4859
Made in China

HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78553-4339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78553-4339-3	3 in 1 BLISTER PACK	08/12/2020	06/30/2023
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/12/2020	06/30/2023

Labeler - Unitrex Ltd. (062032343)

Revised: 1/2023

Document Id: f172451d-17bb-5db2-e053-2a95a90a5644

34390-5

Set id: ad1a4730-13a5-46e1-e053-2a95a90a2311

Version: 2

Effective Time: 20230104

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