BATHEAL HAND SANITIZING WIPES- hand sanitizing wipes cloth
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)

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use(s)

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For External use only. For children under 3 years of age, consult with a doctor before use.

Do not use

on large areas of the body
if you are allergic to any of the ingredients

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

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

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

Directions

For adults and children of 3 years and over, wet hands thoroughly with product and allow to dry.
Supervise children under 6 years of age when using this product.

Other information

Store at room temperature

Inactive ingredients

Water, Alcohol, Sodium Hydroxide, Fragnance

Package Label - Principal Display Panel

NDC 75272-004-30

BATHEAL HAND SANITIZING WIPES
hand sanitizing wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75272-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75272-004-30	450 g in 1 PACKET; Type 0: Not a Combination Product	06/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/08/2020

Labeler - SUNJU CORPORATION (694816019)

Name	Address	ID/FEI	Business Operations
Establishment
SHINE CO.,LTD		688437450	manufacture(75272-004)