CLEANOVA GEL HAND SANITIZER- alcohol gel

Cleanova Gel Hand Sanitizer by

Drug Labeling and Warnings

Cleanova Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Pantero, Frestedt Incorporated, Pantero Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that can potentially 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

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

STOP USE

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

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 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• May discolor some fabrics
• May damage wood finishes or plastics

Inactive ingredients

Fragrance, glycerin, isopropyl alcohol, PER-6 (and) AMP-acrylates/vinyl isodecanoate crosspolmer, purified water USP

Package Label - Principal Display Panel

946 mL NDC: 74153-361-32

4730 mL NDC: 74153-361-05

INGREDIENTS AND APPEARANCE

CLEANOVA GEL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74153-361
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
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74153-361-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
2	NDC: 74153-361-05	4730 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/06/2020

Labeler - Pantero (116669041)

Registrant - Frestedt Incorporated (018853696)

Establishment
Name	Address	ID/FEI	Business Operations
Pantero Inc.		116669041	relabel(74153-361) , repack(74153-361)