HEALTH E ALCOHOL-FREE ANTISEPTIC- benzalkonium chloride cloth

HEALTH E Alcohol-Free Antiseptic by

Drug Labeling and Warnings

HEALTH E Alcohol-Free Antiseptic by is a Otc medication manufactured, distributed, or labeled by Petra Hygienic Systems Int Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

• For hand sanitizing to decrease bacteria on the skin.

Warnings

For external use only

May irritate eyes

Keep out reach of children

unless under adult supervision

Directions

• Tear V notch located on top of the plastic bag.
• Pull out the first wipe approximately 6 to 8 inches from the center of the roll.
• Place entire bag inside of center pull dispenser.
• Thread the wipe through the opening on the dispenser.
• Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.
• Apply topically to the skin to help prevent cross contamination.
• Recommended for repeated use.
• Dries in seconds.

Inactive Ingredients

Aloe barbadensis extract, diazolidinyl urea, fragrance, glycerin, lauryl betain, methylparaben/ethylparaben/propylparaben/butylparaben /isobutylparaben/phenoxyethanol, PEG-40 hydrogenated castor oil, propylene glycol, water.

Package Labeling:

INGREDIENTS AND APPEARANCE

HEALTH E ALCOHOL-FREE ANTISEPTIC 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42326-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL BETAINE (UNII: Y4P927Q133)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42326-090-01	1000 in 1 BAG	04/14/2020
1		1.3 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/14/2020

Labeler - Petra Hygienic Systems Int Ltd (248228199)