EZ-448 Antibacterial Moist Hand: Package Insert and Label Information

EZ-448 ANTIBACTERIAL MOIST HAND- benzalkonium chloride swab
Ez Products Of South Florida, LLC

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 0.11%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use

in the eyes.

Do not flush.

Discontinue use if

irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

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

Directions

  • Open label, remove one wipe, and unfold.
  • Wet hands thoroughly with product and allow to dry without wiping. Do not flush.

Other information

  • Store below 95°F (35°C).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Propylene Glycol, Phenoxythanol, Polyaminopropyl Biguanide, Lauryl Glucoside, Tetrasodium EDTA, 2-Broma-2-Nitropropane-1,3-Diol, Chamomilla Recutita Extract, Aloe Barbadensis Leaf Juice Powder, Citric Acid, Sodium Citrate

Package Labeling:

Label
(click image for full-size original)
Box
(click image for full-size original)

EZ-448 ANTIBACTERIAL MOIST HAND
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69446-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.11 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
PHENOXYETHANOL
LAURYL GLUCOSIDE
EDETATE SODIUM
BRONOPOL
ALOE VERA LEAF
CITRIC ACID MONOHYDRATE
SODIUM CITRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69446-200-00 20 PATCH in 1 PACKAGE contains a PATCH
1 2.85 g in 1 PATCH This package is contained within the PACKAGE (69446-200-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 12/17/2017
Labeler — Ez Products Of South Florida, LLC (113456060)

Revised: 02/2018 Ez Products Of South Florida, LLC

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