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- isopropyl alcohol gel 
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:

Isopropyl 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 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. 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, Carbomer

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PACKAGED & DISTRIBUTED BY

Custom Chemical Services, LLC

8230 FM 2004

Hitchcock, TX 77563

(409) 925-7818

HYGIENI-KLEAN HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78174-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75.0 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.17 L  in 100 L
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) 0.08 L  in 100 L
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.66 L  in 100 L
WATER (UNII: 059QF0KO0R) 24.09 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78174-007-013.7854 L in 1 JUG; Type 0: Not a Combination Product06/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/03/202004/12/2021
Labeler - Custom Chemical Services, LLC (078305908)
Establishment
NameAddressID/FEIBusiness Operations
Custom Chemical Services, LLC078305908manufacture(78174-007)

Revised: 4/2021