KERI CLINICAL CARE HAND SANITIZING GEL- hand sanitizer gel 
Crown Laboratories

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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Keri Clinical Care Hand Sanitizing Gel

Active Ingredients

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

  • Hand sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not use

  • On children less than 2 months of age.
  • On open skin wounds.

When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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 15-30°C (59-86°F). Avoid freezing. Protect from excessive heat above 40°C (104°F). May discolor certain fabrics or surfaces.

Inactive Ingredients


denatonium benzoate, fragrance, glycerin, polyacrylate crosspolymer-6, propanediol, purified water, tert-butyl alcohol, tocopherol acetate (vitamin E).

Questions?

800.877.8869

Manufactured and Distributed by:

Crown Laboratories, Inc.,

Johnson City, TN 37604

Made in USA

KERI is a registred trademark of Crown Laboratories, Inc.

Keri Clinical 8fl oz Label

Keri

Clinical Care

Hand Sanitizng Gel

Refreshing Gel with Moisurizers & Vitamin E

P11827.00

8 fll oz Label

KERI CLINICAL CARE HAND SANITIZING GEL 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0292
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPANEDIOL (UNII: 5965N8W85T)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-0292-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/202007/31/2022
2NDC:0316-0292-283785 mL in 1 JUG; Type 0: Not a Combination Product09/15/202009/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/202007/31/2022
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-0292)

Revised: 10/2021
Document Id: ceb8db84-8d40-39ae-e053-2995a90a207f
Set id: aa16f13e-92f6-7ddc-e053-2a95a90afac4
Version: 4
Effective Time: 20211019
 
Crown Laboratories