OSEQUE SAFETY HAND WET WIPES- benzalkonium chloride cloth 
SONGHAK 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

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

Image of packet

OSEQUE SAFETY HAND WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59370-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1   in 100 
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59370-150-0120 in 1 PACKET; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2020
Labeler - SONGHAK CO., LTD. (688237512)
Registrant - SONGHAK CO., LTD. (688237512)
Establishment
NameAddressID/FEIBusiness Operations
NAICO694725335manufacture(59370-150)

Revised: 7/2020
Document Id: fa1defe4-4f40-44f7-9f7d-23508477ed74
Set id: 83066bb9-d3b3-4b03-bb3d-2cbf13e8a208
Version: 1
Effective Time: 20200723
 
SONGHAK CO., LTD.