CLEAN N FRESH INSTANT HAND SANITIZER ANTIBACTERIAL- alcohol gel
CarrollCLEAN 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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Clean N Fresh (R) Hand Sanitizer

Active Ingredient

Ethyl Alcohol 62%v/v

Purpose

Antiseptic

Uses

* To sanitize hands without requiring water or a rinse

* Kills 99.9% of most common bacteria in 15 seconds.

Warnings

FLAMMABLE

For external use only

When using this product

* Do not use near heat or flame do not use in or near eyes

* Discontinue use if irritation and redness develop

* Do not use on deep or puncture wounds, consult your doctor.

Keep out of reach of children.

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

* Apply liberally to unsoiled hands and rub in thoroughly

* Allow to dry without wiping or rinsing.

Other information

Store at room temperature.

Inactive Ingredients:

Water, Carbomer, Glycerin, Diisopropylamine, Isopropyl Myristate

Product Label

CNF 1 gal

CLEAN N FRESH INSTANT HAND SANITIZER ANTIBACTERIAL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73708-514
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	147 mL in 236 mL

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYLAMINE (UNII: BR9JLI40NO)	0.39 mL in 236 mL
WATER (UNII: 059QF0KO0R)	87.17 mL in 236 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.45 mL in 236 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.23 mL in 236 mL
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)	0.75 mL in 236 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73708-514-28	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2020

Labeler - CarrollCLEAN LLC (081222623)

Name	Address	ID/FEI	Business Operations
Establishment
CarrollCLEAN		081222623	manufacture(73708-514)