Clenova Hand Sanitizer (362 gel)

Clenova Gel Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

CLENOVA GEL HAND SANITIZER- alcohol gel 
Pantero

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 Hand Sanitizer (362 gel)

Active Ingredient(s)

Ethyl 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 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, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, purified water USP

Package Label - Principal Display Panel

059 mL NDC: 74153-362-02

118 mL NDC: 74153-362-04

237 mL NDC: 74153-362-08

355 mL NDC: 74153-362-12

473 mL NDC: 74153-362-16

532 mL NDC: 74153-362-18

946 mL NDC: 74153-362-32

3785 mL NDC: 74153-362-01

CLENOVA GEL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74153-362(NDC: 75029-200)
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
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74153-362-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
2	NDC: 74153-362-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	09/30/2020
3	NDC: 74153-362-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
4	NDC: 74153-362-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	09/30/2020
5	NDC: 74153-362-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
6	NDC: 74153-362-18	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	09/30/2020
7	NDC: 74153-362-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
8	NDC: 74153-362-01	3785 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	09/10/2021

Labeler - Pantero (116669041)

Registrant - Frestedt Incorporated (018853696)

Establishment
Name	Address	ID/FEI	Business Operations
Pantero		116669041	relabel(74153-362) , repack(74153-362)

Revised: 9/2021

Document Id: cbab043c-9714-1d30-e053-2a95a90aefb0

34390-5

Set id: a9b63f07-0c16-a706-e053-2a95a90a372d

Version: 4

Effective Time: 20210910