Clean Lyfe Hand Sanitizer

HSC70 by

Drug Labeling and Warnings

HSC70 by is a Otc medication manufactured, distributed, or labeled by Integrity Bio-Chemicals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HSC70- ethanol 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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Clean Lyfe Hand Sanitizer

Drug Facts

Active Ingredien(s) Ethyl Alcohol 70% v/v

Purpose Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause decrease.  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. They 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  Carbomer, Glycerin, Water

Package Label

Clean Lyfe

HAND SANITIZER

UNSCENTED

MOISTURIZING GEL

1 US Gallon (3.79 L) 70% Alcohol

Manufactured by:

Integrity BioChem

Cresson, TX, 76035

integritybiochem.com

LOT#                       NDC: 75512-042-01

1 GAL  

325 Gal

500 mL

res

HSC70 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75512-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75512-042-01	3.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2020	07/01/2022
2	NDC: 75512-042-05	1230.26 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	12/14/2020	07/01/2022
3	NDC: 75512-042-09	0.50 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2020	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/14/2020	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(75512-042)

Revised: 7/2022

Document Id: 38b11d41-b814-4f1c-8c4f-46ac952aa03e

34390-5

Set id: 205c47d2-24f9-401a-8136-4503544c4e57

Version: 3

Effective Time: 20220720