Kleen Care Gel Hand Sanitizer

Kleen Care Hand Sanitizer by

Drug Labeling and Warnings

Kleen Care Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by US Continental. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KLEEN CARE HAND SANITIZER- isopropyl alcohol gel 
US Continental

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.

----------

Kleen Care Gel Hand Sanitizer

Active Ingredient(s)

Isopropyl Alcohol 65% v/v.

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

  • in children less than 2 months of age
  • on open skin wounds

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 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.

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

acrylates/ C10-30 alkyl acrylates, glycerin, propylene glycol, triethanolamine, water

Package Label - Principal Display Panel

label

KLEEN CARE HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76533-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76533-003-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202006/26/2021
2NDC: 76533-003-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202006/26/2021
3NDC: 76533-003-03177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202006/26/2021
4NDC: 76533-003-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202006/26/2021
5NDC: 76533-003-053785 mL in 1 JUG; Type 0: Not a Combination Product03/30/202006/26/2021
6NDC: 76533-003-0618927 mL in 1 PAIL; Type 0: Not a Combination Product03/30/202006/26/2021
7NDC: 76533-003-07208190 mL in 1 DRUM; Type 0: Not a Combination Product03/30/202006/26/2021
8NDC: 76533-003-08946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202006/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202006/26/2021
Labeler - US Continental (793141912)
Establishment
NameAddressID/FEIBusiness Operations
US Continental793141912manufacture(76533-003)

Revised: 1/2022
Document Id: d686d0a1-2dd4-57a9-e053-2a95a90a939a
Set id: ab37e56b-e7c1-adbf-e053-2a95a90acc72
Version: 4
Effective Time: 20220126
 
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.