CLENOVA HAND SANITIZER, 70% ISOPROPYL ALCOHOL by PANTERO, INC. CLENOVA IPA 70% GEL

CLENOVA HAND SANITIZER, 70% ISOPROPYL ALCOHOL by

Drug Labeling and Warnings

CLENOVA HAND SANITIZER, 70% ISOPROPYL ALCOHOL by is a Otc medication manufactured, distributed, or labeled by PANTERO, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLENOVA HAND SANITIZER, 70% ISOPROPYL ALCOHOL- isopropyl alcohol 70% gel 
PANTERO, INC.

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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CLENOVA IPA 70% GEL

Active Ingredient

Isopropyl 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 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 six years of age when using this product to avoid swallowing.

Other Information

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

Inactive Ingredients

Fragrance, Glycerin, Hydrogen Peroxide, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Purified Water USP

Questions or Comments?

1-833-726-8376, www.clenova.com

Package Label - Principle Display Panel

59mL Bottle, NDC: 74153-282-02:

3785mL Jug, NDC: 74153-282-01:

473mL Bottle, NDC: 74153-282-16:

CLENOVA HAND SANITIZER, 70% ISOPROPYL ALCOHOL 
isopropyl alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74153-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74153-282-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2020
2	NDC: 74153-282-01	3785 mL in 1 JUG; Type 0: Not a Combination Product	11/17/2020
3	NDC: 74153-282-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/17/2020	09/10/2021

Labeler - PANTERO, INC. (116669041)

Establishment
Name	Address	ID/FEI	Business Operations
PANTERO, INC.		116669041	manufacture(74153-282) , pack(74153-282) , label(74153-282) , relabel(74153-282) , repack(74153-282)

Revised: 9/2021

Document Id: cbaaf4c6-77ea-ba2c-e053-2995a90a5cda

34390-5

Set id: b454ce1a-3a76-33a5-e053-2995a90af5b2

Version: 4

Effective Time: 20210910