BATHEAL HAND SANITIZER- hand sanitizer gel 
SUNJU CORPORATION

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(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use(s)

To help reduce bacteria and germs on the skin.

Warnings

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

Do not use

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.

Directions

Other information

Inactive ingredients

Water, Sodium Hyaluronate, Glycerin, Lemon Oil, Carbormer, Tromethamine, Fragrance

Package Label - Principal Display Panel

500mL NDC: 75272-001-10 500mL NDC: 75272-001-10

BATHEAL HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75272-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LEMON OIL (UNII: I9GRO824LL)  
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
TROMETHAMINE (UNII: 023C2WHX2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75272-001-10500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2020
Labeler - SUNJU CORPORATION (694816019)
Establishment
NameAddressID/FEIBusiness Operations
INNOSKIN CO., LTD.695625879manufacture(75272-001)

Revised: 5/2020
Document Id: a68773f3-cabf-3db3-e053-2995a90a0ef5
Set id: a3e2584a-998b-8882-e053-2995a90a5386
Version: 3
Effective Time: 20200526
 
SUNJU CORPORATION