BATHEAL HAND SANITIZER- hand sanitizer gel

BATHEAL HAND SANITIZER by

Drug Labeling and Warnings

BATHEAL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by SUNJU CORPORATION, INNOSKIN CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% 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

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

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

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 briskly until dry.
• Supervise children 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

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

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

BATHEAL HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75272-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	3 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL)	2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	14 mL  in 100 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	5 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)	0.5 mL  in 100 mL
TROMETHAMINE (UNII: 023C2WHX2V)	0.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75272-003-30	100 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/21/2020

Labeler - SUNJU CORPORATION (694816019)

Establishment
Name	Address	ID/FEI	Business Operations
INNOSKIN CO., LTD.		695625879	manufacture(75272-003)