PETRA HEALTH E WIPES ALCOHOL FREE ANTISEPTIC- benzalkonium chloride cloth

Petra Health E Wipes Alcohol Free Antiseptic by

Drug Labeling and Warnings

Petra Health E Wipes 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

To dispense: Flip front lid unward and remove wipes. To Reseal: Snap hinged lid back into place to ensure wipes stay moist.

Wet hand thoroughly with product and allow to dry.

Discard wipe in trash receptacle after use. Do not flush.

Children under 6 years of age should be supervised in using this product.

Inactive Ingredients

Water/Aqua/Eau, Glycerin, Propylene Glycol, Lauryl Betain, Phenoxyethanol, Aloe Barbadensis Extract, PEG-40 Hydrogenated Castor Oil, Diazolidinyl Urea, Fragrance/Parfum, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

PETRA HEALTH E WIPES ALCOHOL FREE ANTISEPTIC 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42326-100
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAURYL BETAINE (UNII: Y4P927Q133)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42326-100-60	60 in 1 BAG	05/14/2020
1		0.0013 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 42326-100-01	1 in 1 BAG	11/30/2020
2		0.0013 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 Drug	505G(a)(3)	05/14/2020

Labeler - Petra Hygienic Systems Int Ltd (248228199)