Germinac by Sentel Chemical, LLC / Arropol Chemicals, LLC Germinac

Germinac by

Drug Labeling and Warnings

Germinac by is a Otc medication manufactured, distributed, or labeled by Sentel Chemical, LLC, Arropol Chemicals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GERMINAC- alcohol gel 
Sentel Chemical, 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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Germinac

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can 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.

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 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

carbomer, fragrance, glycerin, trolamine, water

Package Label - Principal Display Panel

79240-268 Representative Label

GERMINAC 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79240-268
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
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79240-268-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/07/2020
2	NDC: 79240-268-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/07/2020	12/31/2021

Labeler - Sentel Chemical, LLC (037383888)

Registrant - Sentel Chemical, LLC (037383888)

Establishment
Name	Address	ID/FEI	Business Operations
Arropol Chemicals, LLC		007806457	manufacture(79240-268)

Revised: 1/2022

Document Id: d578a324-6659-2d83-e053-2a95a90a2bc5

34390-5

Set id: a9dbe436-54d4-a638-e053-2995a90aa7c7

Version: 2

Effective Time: 20220113