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

Hygieni-Klean Hand Sanitizer Gel Healthcare Grade by

Drug Labeling and Warnings

Hygieni-Klean Hand Sanitizer Gel 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 GEL HEALTHCARE GRADE- ipa 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 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, Carbomer

image description

HYGIENI-KLEAN HAND SANITIZER GEL HEALTHCARE GRADE 
ipa gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78174-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL80.0836 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.0661 L  in 100 L
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) 0.4798   in 100 L
water (UNII: 059QF0KO0R) 19.3705 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78174-031-013.78541 L in 1 JUG; Type 0: Not a Combination Product01/03/2021
2NDC: 78174-031-020.946353 L in 1 BOTTLE; Type 0: Not a Combination Product01/03/2021
3NDC: 78174-031-030.473176 L in 1 BOTTLE; Type 0: Not a Combination Product01/03/2021
4NDC: 78174-031-040.354882 L in 1 BOTTLE; Type 0: Not a Combination Product01/03/2021
5NDC: 78174-031-050.236588 L in 1 BOTTLE; Type 0: Not a Combination Product01/03/2021
6NDC: 78174-031-060.118294 L in 1 BOTTLE; Type 0: Not a Combination Product01/03/2021
7NDC: 78174-031-070.0591471 L in 1 BOTTLE; Type 0: Not a Combination Product01/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/03/202101/13/2021
Labeler - Custom Chemical Services, LLC (078305908)
Establishment
NameAddressID/FEIBusiness Operations
Custom Chemical Services, LLC078305908manufacture(78174-031)

Revised: 1/2021