Roots by MFG Chemical, LLC.

Roots by

Drug Labeling and Warnings

Roots by is a Otc medication manufactured, distributed, or labeled by MFG Chemical, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROOTS- alcohol liquid 
MFG Chemical, LLC.

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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Active Ingredient

Active Ingredient Purpose

Ethyl Alcohol 80% v/v............................................................................................................................................................. Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Hand Sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from heat 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 rash appears and lasts.

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

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

Directions

• Place enough product in your palm to cover hands and rub hands together until dry.
• Children under 6 years of age should be supervised when using hand sanitizer.

Other Information

• Store below 110°F (43°C)
• May discolor certain fabric or surfaces

Inactive Ingredients

Water (Aqua), Tert-butanol, Glycerin, Polyacrylate, Aminomethyl Propanol

ROOTS 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77809-080
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)	0.125 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	17.375 mL  in 100 mL
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)	1 mL  in 100 mL
GLYCEROL FORMAL (UNII: 3L7GR2604E)	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77809-080-02	7560 mL in 1 JUG; Type 0: Not a Combination Product	05/28/2020	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/28/2020	07/01/2020

Labeler - MFG Chemical, LLC. (066924424)

Establishment
Name	Address	ID/FEI	Business Operations
MFG Chemical, LLC.		066924424	manufacture(77809-080)

Establishment
Name	Address	ID/FEI	Business Operations
MFG Chemical, LLC.		789380354	manufacture(77809-080)

Revised: 7/2020

Document Id: aa02f070-0b90-7852-e053-2995a90a7b65

34390-5

Set id: a5798b03-3dec-a37c-e053-2995a90a7b12

Version: 2

Effective Time: 20200709