HSC62-RM- ethyl alcohol gel

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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredien(s) Ethyl Alcohol 62% v/v

PURPOSE

Purpose Antiseptic

INDICATIONS & USAGE

Uses

Hand sanitizer to help reduce bacteria that potentially can cause decrease.  For use
when soap and water are not available.

WARNINGS

Warnings
For external use only.  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

When using this product keep out of eyes, ears, and mouth. In case

of contact with eyes, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation occurs. They may be signs of

a serious condition.

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

■ Store between 15-30C (59-86F)

■ Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

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  

325 Gal

500 mL

res

INGREDIENTS AND APPEARANCE

HSC62-RM 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75512-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 L  in 100 L

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75512-051-01	3.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2020
2	NDC: 75512-051-05	1230.26 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	12/14/2020
3	NDC: 75512-051-09	0.50 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2020

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

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(75512-051)