ROOTS HAND SANITIZER GEL, FRAGRANCE FREE- alcohol gel

Roots Hand Sanitizer Gel, Fragrance Free by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

Package Labeling:

INGREDIENTS AND APPEARANCE

ROOTS HAND SANITIZER GEL, FRAGRANCE FREE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64987-6322
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: 64987-6322-6	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020

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

Labeler - World Club Supply Corp (061098208)