ANTISEPTIC- benzethonium chloride solution

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by MPM Medical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzethonium chloride 0.1%

Purpose

Antiseptic

Uses

• To clean superficial wounds
• For washing small superfical wounds
• Aids in removal of foreign material such as dirt and debris
• First-aid product

Warnings

For external use only.

This product is not for use on wild or domestic animal bites. If you have an animal bite, consult your physician immediately.

Do not use this product for more than 10 days. If condition worsens or persists, see your physician.

Do not bandage tightly.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

Directions

Apply to affected area.

Adults and children 2 years of age or older: Spray on the affected area up to 3 times per day.

May be covered with a sterile bandage, if bandaged let dry first.

Children under 2 years: Consult a physician prior to use.

Other information

Store at room temperature

Inactive ingredients

Deionized water, disodium EDTA, glycerin, methylparaben, phosphoric acid, polyethylene-polypropylene glycol, sodium hydroxide

Package Label

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
benzethonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66977-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLOXAMER 188 (UNII: LQA7B6G8JG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66977-032-08	237 mL in 1 BOTTLE
2	NDC: 66977-032-02	60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/1997

Labeler - MPM Medical, Inc. (119643406)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories, LLC		055329696	manufacture(66977-032)