JIT HAND SANITIZERS- alcohol gel 
KMPHARMACEUTICAL Co.,Ltd.

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

Active ingredients: ALCOHOL 62.0%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Triethanolamine, Flavor

PURPOSE

Purpose: SANITIZER

WARNINGS

Warnings:

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

When using this product
do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.

Discontinue use if
irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses:
Hand sanitizer to help reduce bacteria on the skin.

Directions

Directions:
Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

JIT HAND SANITIZERS 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50555-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.2 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50555-050-021 in 1 CARTON03/01/2020
1NDC:50555-050-0160 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/01/2020
Labeler - KMPHARMACEUTICAL Co.,Ltd. (688679158)
Registrant - KMPHARMACEUTICAL Co.,Ltd. (688679158)
Establishment
NameAddressID/FEIBusiness Operations
KMPHARMACEUTICAL Co.,Ltd.688679158manufacture(50555-050)

Revised: 4/2020
Document Id: ff357dc6-8d86-4c1f-9450-874d512ee4a4
Set id: 53a62e0a-ccd7-4837-b098-dcc6851c7a8d
Version: 1
Effective Time: 20200408
 
KMPHARMACEUTICAL Co.,Ltd.