Hygieni-Klean Hand Sanitizer by Custom Chemical Services, LLC

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]

HYGIENI-KLEAN HAND SANITIZER- alcohol liquid 
Custom Chemical Services, 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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Active Ingredient:

Alcohol 75% v/v.

Purpose

Antibacterial

Use(s)

Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use. For use when soap and water are not available.

Warnings

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

When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush eyes with water immediately. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists, consult a physician.

Keep out of reach of children. Children should only use this product under adult supervison. Do not drink. Not edible. In case of accidential ingestion, seek professional assistance or contact a Poison Control Center immediately.

Other information 

Store under 105°F. Avoid freezing and excessive heat above 104°F.

Directions

Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

Inactive ingredients

Purified water, Glycerin USP, PEG-600

PACKAGED & DISTRIBUTED BY

Custom Chemical Services, LLC

8230 FM 2004

Hitchcock, TX 77563

(409) 925-7818

HYGIENI-KLEAN HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78174-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.17 L  in 100 L
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)	0.08 L  in 100 L
water (UNII: 059QF0KO0R)	24.75 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78174-004-01	3.78541 L in 1 JUG; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	04/12/2021

Labeler - Custom Chemical Services, LLC (078305908)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Chemical Services, LLC		078305908	manufacture(78174-004)

Revised: 4/2021

Document Id: 959eb5f5-add3-40c7-bf56-a93b971e77ed

34390-5

Set id: 1e0269fb-8693-409a-b6a3-0ebf460545cf

Version: 2

Effective Time: 20210412