Hygieni-Klean Hand Sanitizer Fluid Healthcare Grade by Custom Chemical Services, LLC

Hygieni-Klean Hand Sanitizer Fluid Healthcare Grade by

Drug Labeling and Warnings

Hygieni-Klean Hand Sanitizer Fluid Healthcare Grade 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 FLUID HEALTHCARE GRADE- ipa 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 Ingredients

Isopropanol 80% v/v

Purpose

Antibacterial

Uses Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

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

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 doctor.

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. 

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

HYGIENI-KLEAN HAND SANITIZER FLUID HEALTHCARE GRADE 
ipa liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78174-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	80.0992 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.0662 L  in 100 L
water (UNII: 059QF0KO0R)	19.8346 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78174-034-01	3.78541 L in 1 JUG; Type 0: Not a Combination Product	01/03/2021
2	NDC: 78174-034-02	0.946353 L in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2021
3	NDC: 78174-034-03	0.473176 L in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2021
4	NDC: 78174-034-04	0.354882 L in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2021
5	NDC: 78174-034-05	0.236588 L in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2021
6	NDC: 78174-034-06	0.118294 L in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2021
7	NDC: 78174-034-07	0.0591471 L in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/03/2021	01/13/2021

Labeler - Custom Chemical Services, LLC (078305908)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Chemical Services, LLC		078305908	manufacture(78174-034)

Revised: 1/2021

Document Id: 1cece12d-ceb1-4a35-b17d-765c5ff1cc4b

34390-5

Set id: f3eeebb5-d6a2-49fe-be6e-7c2580cd446b

Version: 2

Effective Time: 20210113