Roots Hand Sanitizer Gel, Fragranced

Roots Hand Sanitizer Gel, Fragranced by

Drug Labeling and Warnings

Roots Hand Sanitizer Gel, Fragranced by is a Otc medication manufactured, distributed, or labeled by World Club Supply Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROOTS HAND SANITIZER GEL, FRAGRANCED- alcohol gel 
World Club Supply Corp

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Roots Hand Sanitizer Gel, Fragranced

Drug Facts

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use(s)

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 heat or flame

Do not use

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

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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.

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.

Other Information

• Store between 15-30ºC (59-86ºF)
• Avoid freezing and excessive heat above 40ºC (104ºF)

Inactive Ingredients

Purified Water, Glycerin, Carbomer, Isopropyl Myristate, Triethanolamine, Polysorbate, Fragrance

Package Labeling:

ROOTS HAND SANITIZER GEL, FRAGRANCED 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64987-6323
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64987-6323-6	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/24/2020	12/31/2024

Labeler - World Club Supply Corp (061098208)

Revised: 2/2025

Document Id: 2e277efd-27b5-e2b8-e063-6294a90a3e53

34390-5

Set id: abfd59e2-c209-d771-e053-2a95a90ad785

Version: 4

Effective Time: 20250214