Clean Lyfe Hand Sanitizer - Rosemary Mint Scented

HSC62-RM by

Drug Labeling and Warnings

HSC62-RM by is a Otc medication manufactured, distributed, or labeled by Integrity Bio-Chemicals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HSC62-RM- ethyl 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.

----------

Clean Lyfe Hand Sanitizer - Rosemary Mint Scented

Drug Facts

Active Ingredien(s) Ethyl Alcohol 62% 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, Fragrance, Glycerin, Water

Package Label

Clean Lyfe

HAND SANITIZER

ROSEMARY MINT SCENTED

MOISTURIZING GEL

1 US Gallon (3.79 L) 62% Alcohol

Manufactured by:

Integrity BioChem

Cresson, TX, 76035

integritybiochem.com

LOT#                           NDC: 75512-051-01

1 GAL  

051-01 1Gal RosMary

325 Gal

051-05 325Gal RosMary

500 mL

051-09 500mL RosMary

res

HSC62-RM 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75512-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75512-051-013.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/202007/01/2022
2NDC: 75512-051-051230.26 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product12/14/202007/01/2022
3NDC: 75512-051-090.50 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/202007/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/14/202007/01/2022
Labeler - Integrity Bio-Chemicals, LLC (080873668)
Registrant - Integrity Bio-Chemicals, LLC (080873668)
Establishment
NameAddressID/FEIBusiness Operations
Integrity Bio-Chemicals, LLC080873668manufacture(75512-051)

Revised: 7/2022
Document Id: 8bf7274d-e7cc-43af-98d4-c87a771d102f
Set id: 3fc82c64-18e8-4520-88df-b6909d7e8254
Version: 2
Effective Time: 20220720