Integrity Biochem Hand Sanitizer

HS100 by

Drug Labeling and Warnings

HS100 by is a Otc medication manufactured, distributed, or labeled by Integrity Bio-Chemicals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HS100- alcohol gel 
Integrity Bio-Chemicals, 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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Integrity Biochem Hand Sanitizer

Drug Facts

Active Ingredient[s]  Alcohol 80% v/v

Purpose Antiseptic

Use(s)
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
On 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 thoroughly with water.

Stop use and ask a doctor if irritation 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 the
product to avoid swallowing.

Other information
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients: glycerin, *hydroxypropyl cellulose,
*hydroxypropyl methylcellulose, water
*May or may not include

Package Label - Principal Display panel

INTEGRITY

BIOCHEM

Hand Sanitizer

HS100

80% Alcohol

3.79 L (1 US gal.)            Moisturizing Gel

        Manufactured by: INTEGRITY BIOCHEM

                CRESSON, TX 76035

           www.integritybiochem.com

NDC: 75512-002-01                       0  51497 17025  7

res

HS100 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75512-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75512-002-01	3.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2020	07/01/2022
2	NDC: 75512-002-02	18.95 L in 1 PAIL; Type 0: Not a Combination Product	05/04/2020	07/01/2022
3	NDC: 75512-002-03	208.45 L in 1 DRUM; Type 0: Not a Combination Product	05/04/2020	07/01/2022
4	NDC: 75512-002-04	1023.3 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/04/2020	07/01/2022
5	NDC: 75512-002-05	1231.75 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/04/2020	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/04/2020	07/01/2022

Labeler - Integrity Bio-Chemicals, LLC (080873668)

Registrant - Integrity Bio-Chemicals, LLC (080873668)

Establishment
Name	Address	ID/FEI	Business Operations
Integrity Bio-Chemicals, LLC		080873668	manufacture(75512-002)

Revised: 7/2022

Document Id: 00946a83-77aa-49f8-887c-93260fbc62c7

34390-5

Set id: 04d525d7-0789-4795-aa80-f7fb3cd64ba5

Version: 4

Effective Time: 20220719