Keep Em Clean by Green Roads Of Florida LLC / Natures Formulae Health Products Ltd.

Keep Em Clean by

Drug Labeling and Warnings

Keep Em Clean by is a Otc medication manufactured, distributed, or labeled by Green Roads Of Florida LLC, Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP EM CLEAN- ethyl alcohol liquid 
Green Roads Of Florida 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.

----------

Ethyl Alcohol (Ethanol) 70% v/v

Purpose:

Antiseptic

Uses:

Hand sanitizer to help reduce bacteria on the skin.

WARNINGS:

Flammable. Keep away from fire 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 lasts.

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

Directions:

• Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry.
• Children under 6 years of age should be supervised when using this product.

• Do not store above 104F
• May discolor some fabrics. Harmful to wood finishes and plastics.

Inactive Ingredients:

Water (Aqua), Carthamus Tinctorius (Safflower) Oleosomes, Glycerin, Polyacrylate Crosspolymer-6, Hydroxyethylcellulose, Sodium Hydroxide

KEEP EM CLEAN 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77351-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77351-001-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	12/31/2022

Labeler - Green Roads Of Florida LLC (041100734)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(77351-001)

Revised: 12/2022

Document Id: f0ff7f26-40f4-5a6f-e053-2a95a90a583b

34390-5

Set id: a7daa449-9ba3-1ba1-e053-2a95a90ac77c

Version: 2

Effective Time: 20221229