TORRENTX WOUND WASH- benzalkonium chloride irrigant

TorrentX by

Drug Labeling and Warnings

TorrentX by is a Otc medication manufactured, distributed, or labeled by Next Science, LLC, Novo Nordisk, Holopack Verpackungstechnik. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

First aid Antiseptic

Uses

First aid to cleanse minor cuts, wounds and scrapes

Directions

Twist off top, squeeze ampoule to wash affected area. Option 17 gauge luer applicator included in box. Apply as needed.

Warnings

• Do not use on burn injuries. Do not use in body orifices, ear canals, eyes or mouth

• Not for injection
• For single use only

• Consult a healthcare professional for continued wound care management and for use on children younger than 2 years of age

• Keep out of reach of children

• Do not use if package is damaged

• If redness, swelling or pain worsens, please seek the advice of your health care practitioner

Other information

• Store between 4°F (-15°C), 80°F (27°C), Avoid sunlight & freezing. Protect from heat sources.

Inactive ingredients

Citric acid, Ethanol, Sodium Citrate, USP Grade Water

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 20 mL Ampule Box

TORRENTX™

Wound Wash

QTY 10 ct – 20mL

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NEXT SCIENCE®

INGREDIENTS AND APPEARANCE

TORRENTX   WOUND WASH
benzalkonium chloride irrigant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70858-0001
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
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Alcohol (UNII: 3K9958V90M)
Trisodium Citrate Dihydrate (UNII: B22547B95K)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70858-0001-1	10 in 1 BOX	09/20/2018
1		20 mL in 1 AMPULE; 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	part333A	09/20/2018

Labeler - Next Science, LLC (043989331)

Establishment
Name	Address	ID/FEI	Business Operations
Next Science Manufacturing, LLC		080177190	LABEL(70858-0001) , ANALYSIS(70858-0001)

Establishment
Name	Address	ID/FEI	Business Operations
Holopack Verpackungstechnik		343390324	PACK(70858-0001) , MANUFACTURE(70858-0001)

Establishment
Name	Address	ID/FEI	Business Operations
Novo Nordisk		305914798	API MANUFACTURE(70858-0001)