JUC Sterilization Wipes: Package Insert and Label Information

JUC STERILIZATION WIPES- benzalkonium chloride cloth
NMS Technologies 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.

Active ingredient

Benzalkonium chloride 3mg/mL. Purpose: Antimicrobial

Purpose

Antimicrobial.

When using

avoid direct contact with eyes and damaged skin.

Do not use

Do not replace wipes used for medical procedures.

Stop use

Stop use if there is discomfort, please immediately seek medical attention.

Keep out of reach of children

This product should be placed out of reach of children.

Indications & usage

This product can be directly wiped to form a physical antimicrobial film to kill Escherichia coli, Staphylococcus aureus.

Directions

Unpack and unfold the wipes. From one side of the skin or surface of the object, wipe orderly to cover the entire surface.

Warnings

This product avoids direct contact with eyes and damaged skin.

Other information

Storage: Avoids light, sealed and stored in a cool place.

Inactive ingredient

Water.

Package label. Principal display panel

W080
(click image for full-size original)

JUC STERILIZATION WIPES
wipes cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78128-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 8 mg
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78128-101-27 80 CLOTH in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/27/2020
Labeler — NMS Technologies Co., Ltd. (527216960)
Registrant — A03 Lab of BTS (548009541)
Establishment
Name Address ID/FEI Operations
NMS Technologies Co., Ltd. 527216960 manufacture (78128-101), label (78128-101)

Revised: 05/2020 NMS Technologies Co., Ltd.

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