BENZALKONIUM CHLORIDE- antibacterial wet wipes swab

Benzalkonium Chloride by

Drug Labeling and Warnings

Benzalkonium Chloride by is a Otc medication manufactured, distributed, or labeled by Diamond Wipes International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Antimicrobial

Active Ingredient

Benzalkonium Chloride 0.13%

Uses

• For hand sanitizing to decrease bacteria on the skin
• Safe for repeated use

Directions

• Peel back label
• remove and unfolod wipe
• wipe hands thoroughly for approximately 30 seconds
• dispose of used wipe in trash, do not flush

Warnings

For external use only

When using this product avoid contact with eyes, if in eyes rinse thoroughly with water

Discontinue use and ask a doctor if irritation and redness develops and conditions persist for more than 72 hours.

Keep Out Of Reach Of Children

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

Aloe barbadensis leaf juice, citric acid, fragrance, glycerin, hamamelis virginiana (witch hazel) bark/leaf/twig/extract, phenoxyethanol, polysorbate 20, tocopheryl acetate, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE 
antibacterial wet wipes swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64709-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
WITCH HAZEL (UNII: 101I4J0U34)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
polysorbate 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64709-100-20	75 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2016

Labeler - Diamond Wipes International (161104729)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes International		161104729	manufacture(64709-100)