CORECHEM Inc. - Hand Sanitizer Gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER GEL- 70% ethyl alcohol gel 
CORECHEM 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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CORECHEM Inc. - Hand Sanitizer Gel

Active Ingredient

Ethyl alcohol 70% v/v / Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Use

Hand sanitizer to decrease bacteria on the skin that could cause diease.

For use when soap and water are not available.

Warnings

Warnings

For external use only: hands
Flammable. Keep away from heat or flame.

Do not use

Do not use

on children less than 2 months of age

on open skin wounds

When using this product

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 and lasts.

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

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

Other information
Do not store above 115°F

May discolor some fabrics.
May damage wood finishes or plastics.

Inactive ingredients

Inactive ingredients
Glycerin, isopropyl alcohol, PEG-6 (and) AMP-acrylates/vinyl
isodecanoate crosspolymer, purified water

Package Label - Principle Display Panel

HAND SANITIZER GEL

KILLS 99.9% OF GERMS*

*Effectively eliminates 99.9% of most illness causing germs and bacteria.

Made in USA

Manufactured by CORECHEM Inc.
Knoxville, TN
1-800-258-5829
To reorder: sales@corecheminc.com

CORECHEM - Hand Sanitizer Gel - 8oz (237 ml) - NDC: 75029-100-05

CORECHEM - Hand Sanitizer Gel - 16oz (473 ml) - NDC: 75029-100-08

CORECHEM - Hand Sanitizer Gel - 33.8oz (1L) - NDC: 75029-100-20

CORECHEM - Hand Sanitizer Gel - 1 gallon (3.785 L) - NDC: 75029-100-30

CORECHEM - Hand Sanitizer Gel - 55 gallon (208 L) - NDC: 75029-100-60

CORECHEM - Hand Sanitizer Gel - 275 gallon (1040 L) - NDC: 75029-100-70

HAND SANITIZER GEL 
70% ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75029-100
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)	0.91 mL  in 100 mL
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)	1.42 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75029-100-05	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/02/2020
2	NDC: 75029-100-30	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/02/2020
3	NDC: 75029-100-60	208198 mL in 1 DRUM; Type 0: Not a Combination Product	06/02/2020
4	NDC: 75029-100-70	1040988 mL in 1 TANK; Type 0: Not a Combination Product	06/02/2020
5	NDC: 75029-100-20	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/02/2020
6	NDC: 75029-100-08	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020	11/30/2022

Labeler - CORECHEM Inc. (070056445)

Revised: 11/2022

Document Id: ee4cfe6c-bde6-0e70-e053-2995a90aee97

34390-5

Set id: a5584208-bb46-606f-e053-2995a90a055b

Version: 13

Effective Time: 20221125