OSEQUE SAFETY HAND WET WIPES by SONGHAK CO., LTD. / NAICO

OSEQUE SAFETY HAND WET WIPES by

Drug Labeling and Warnings

OSEQUE SAFETY HAND WET WIPES by is a Otc medication manufactured, distributed, or labeled by SONGHAK CO., LTD., NAICO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OSEQUE SAFETY HAND WET WIPES- benzalkonium chloride cloth 
SONGHAK CO., LTD.

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ACTIVE INGREDIENT

Benzalkonium Chloride 0.1%

INACTIVE INGREDIENTS

Water, Glycerin, Sodium Benzoate, Polysorbate 20, Ethylhexylglycerin,, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Fragrance

PURPOSE

Antiseptic

WARNINGS

For external use only
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Do not use
■ on infants
■ on open skin wounds
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When using this product
■ avoid getting into the eyes
■ In case of eye contact immediately flush eyes thoroughly with water
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Stop use and ask a doctor
■ if irritation or redness develops
■ conditions persist for more than 72 hours
■ redness is present

KEEP OUT OF REACH OF CHILDREN

■ in case of accidental ingestion, contact a doctor or Poison Center immediately

Uses

■ hand sanitizing wipes to help reduce bacteria on the skin. For use when soap and water not available

Directions

■ thoroughly wipes hands with cloth
■ rub hands together until dry

Other information

■ Storage in a cool, dry place, Avoid freezing and excessive heat above 40 ℃ (104 ℉)
■ Do not flush

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OSEQUE SAFETY HAND WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59370-150
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59370-150-01	20 g in 1 PACKET; Type 0: Not a Combination Product	07/01/2020	12/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	07/01/2020	12/30/2020

Labeler - SONGHAK CO., LTD. (688237512)

Registrant - SONGHAK CO., LTD. (688237512)

Establishment
Name	Address	ID/FEI	Business Operations
NAICO		694725335	manufacture(59370-150)

Revised: 12/2024

Document Id: 28fa4b17-b857-fdce-e063-6294a90a5b25

34390-5

Set id: 83066bb9-d3b3-4b03-bb3d-2cbf13e8a208

Version: 2

Effective Time: 20241211