HS100XG- ethyl alcohol gel

HS100XG by

Drug Labeling and Warnings

HS100XG 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 Ingredient[s]  Alcohol 80%

PURPOSE

Purpose Antiseptic

INDICATIONS & USAGE

Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease.  For use when soap and water are not available.

WARNINGS

Warnings
For external use only.  Flammable. Keep away from fire or flame

DO NOT USE

Do not use

in 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 or rash occurs. These 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 this 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: glycerin, hydrogen peroxide, water

Package Label

INTEGRITY                                                                        Lot #:

BIOCHEM

HS100

Alcohol Antiseptic 80% Topical Gel

Hahd Sanitizer

Non-sterile Solution

3.79 L (1 Gal)

Made in USA

Before handling this material, read accompanying

Safety Data Sheet for more detailed safety, health

and environmental data.

        Manufactured by: Integrity Biochem

1100 NORTH CRESSON HWY  CRESSON, TX 76035

                                           PHONE: (817) 402-0444

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INGREDIENTS AND APPEARANCE

HS100XG 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75512-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75512-001-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/16/2020

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(75512-001)