BENZALKONIUM CHLORIDE cloth

BENZALKONIUM CHLORIDE by

Drug Labeling and Warnings

BENZALKONIUM CHLORIDE by is a Otc medication manufactured, distributed, or labeled by ASP Global, LLc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

for preparation of the skin prior to an injection.

Warnings

For external use only. Flammable, keep away from fire or flame. Do not use with electrocautery procedures or near eyes. Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply topically as needed to clean intended area. Discard after single use.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Disodium EDTA, DMDM Hydantoin, Ethylparaben, Methylparaben, Phenoxyethanol, Polysorbate 20, Sodium Citrate, Water

PRINCIPAL DISPLAY PANEL - 10 Applicator Package

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INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-010
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Water (UNII: 059QF0KO0R)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-010-01	10 in 1 PACKAGE	02/28/2022
1		6.2 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	02/28/2022

Labeler - ASP Global, LLc (080361159)

Registrant - ASP Global, LLc (080361159)