BZK ANTISEPTIC TOWELETTE: Package Insert and Label Information

BZK ANTISEPTIC TOWELETTE — benzalkonium chloride swab
Yinjing Medical Technology (Shanghai) 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.

Drug Facts

Active ingredient

Benzalkonium Chloride, 0.13% w/v

Purpose

First Aid Antiseptic

Use

First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.

Warnings

For external use only.

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor.

Consult a doctor

in case of deep or puncture wounds, animal bites, or serious burns.

Stop use and consult a doctor

if the condition persists or gets worse.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the affected area
  • Apply a small amount of this product on the area 1 to 3 times daily
  • May be covered with a sterile bandage when dry

Inactive ingredients

purified water, sodium bicarbonate

Shanghai Yinjing Medical Supplies Co., Ltd.
586 Yuanxi RD.Nanhui Industry Park,Shanghai 201300
Tel:+86-21-6801-6511 Http://www.yinjing.cn
E-mail: zhl@yinjing.cn
Made in China
LOT

NDC:44019-323-01
inin 1 pad/pouch
BZK ANTISEPTIC TOWELETTE
For External Use Only

Product Label

BZK antiseptic towelette
(click image for full-size original)

BZK ANTISEPTIC TOWELETTE benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44019-323
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44019-323-01 1 PATCH in 1 POUCH contains a PATCH
1 1.5 g in 1 PATCH This package is contained within the POUCH (44019-323-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/03/2016
Labeler — Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
Registrant — Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)

Revised: 12/2017 Yinjing Medical Technology (Shanghai) Co., Ltd.

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