HYGIENI-KLEAN HAND SANITIZER- alcohol gel

Hygieni-Klean Hand Sanitizer by

Drug Labeling and Warnings

Hygieni-Klean Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Custom Chemical Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only. Flammable. Keep away from heat or flame

Purpose

Antiseptic, Hand Sanitizer

Active Ingredient:

Alcohol 70% v/v. Purpose: Antiseptic

Use

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

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 eyes thoroughly with water.
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. If swallowed, get medical help or contact a Poison Control Center right away.

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.

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 information

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

Inactive ingredients

purified water, glycerin, PEG-600, carbomer

Package Label - Principle Display Panel

INGREDIENTS AND APPEARANCE

HYGIENI-KLEAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78174-001
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
GLYCERIN (UNII: PDC6A3C0OX)	0.25 L  in 100 L
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)	0.1 L  in 100 L
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)	0.75 L  in 100 L
water (UNII: 059QF0KO0R)	28.9 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78174-001-01	3.78541 L in 1 JUG; Type 0: Not a Combination Product	05/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/03/2020

Labeler - Custom Chemical Services, LLC (078305908)

Registrant - Custom Chemical Services, LLC (078305908)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Chemical Services, LLC		078305908	manufacture(78174-001)