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NDC 66977-0032-08 Antiseptic 1 mg/mL Details

Antiseptic 1 mg/mL

Antiseptic is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by MPM Medical, LLC. The primary component is BENZETHONIUM CHLORIDE.

Product Information

NDC	66977-0032
Product ID	66977-032_d9bad895-34ba-dd32-e053-2995a90a795a
Associated GPIs	92100022100910
GCN Sequence Number	051623
GCN Sequence Number Description	benzethonium chloride CLEANSER 0.1 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	18951
HICL Sequence Number	004259
HICL Sequence Number Description	BENZETHONIUM CHLORIDE
Brand/Generic	Generic
Proprietary Name	Antiseptic
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzethonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	mg/mL
Substance Name	BENZETHONIUM CHLORIDE
Labeler Name	MPM Medical, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 66977-0032-08 (66977003208)

Pricing Information	N/A
NDC Package Code	66977-032-08
Billing NDC	66977003208
Package	237 mL in 1 BOTTLE (66977-032-08)
Marketing Start Date	1997-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3f660269-f83d-4f71-9a70-e2ddb2c57ec6 Details

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, 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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66977-032-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1997

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

Labeler - MPM Medical, LLC (081241522)

Revised: 3/2022

Document Id: d9bad895-34ba-dd32-e053-2995a90a795a

Set id: 3f660269-f83d-4f71-9a70-e2ddb2c57ec6

Version: 2

Effective Time: 20220308