FDA.reportPublic FDA data

Antiseptic

Manufacturer
MPM Medical, LLC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:08

Label at a glance#

ProductAntiseptic
Active ingredientBENZETHONIUM CHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzethonium chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Keep out of reach of children.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049095benzethonium chloride 0.1 % Topical SprayPSN4
1049095benzethonium chloride 1 MG/ML Topical SpraySCD4
1049095benzethonium chloride 0.1 % Topical SpraySY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66977-032-082024-05-19C16284748780-19855d018-d50e-cd31-e053-dbdaa90ab51aMP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-082024-01-30C16284748780-19855d018-d50e-cd31-e053-dbdaa90ab51aMP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-022022-03-10C16284748780-19855d018-d50e-cd31-e053-dbdaa90ab51aMP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-082022-03-10C16284748780-19855d018-d50e-cd31-e053-dbdaa90ab51aMP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-022019-11-27C16284748780-19855d018-d50e-cd31-e053-dbdaa90ab51aMP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-082019-11-27C16284748780-19855d018-d50e-cd31-e053-dbdaa90ab51aMP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66977-032-08Antiseptic237 mL in 1 BOTTLESOLUTION2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66977-032-02ML - Milliliter66977-0326000ff1d-42c8-40d1-8ca9-8a2c34d394e512015-10-02
66977-032-08ML - Milliliter66977-032a4674886-b7b6-4200-bab1-98bfdfa8269812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057441
BENZETHONIUMACTIVE MOIETY1VU15B70BP1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NN1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JG1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66977-03266977-032-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLOXAMER 188LQA7B6G8JGIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / TOPICAL0.23 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLOXAMER 188POLOXAMER 188LQA7B6G8JGCREAM / TOPICAL1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLOXAMER 188POLOXAMER 188LQA7B6G8JGCREAM / TOPICAL1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLOXAMER 188POLOXAMER 188LQA7B6G8JGSOLUTION / ORAL1800 mgExact identifier — unii+dosage form
6 equally ranked IID candidates
POLOXAMER 188POLOXAMER 188LQA7B6G8JGSOLUTION / OPHTHALMIC0.1 %w/vExact identifier — unii+dosage form
6 equally ranked IID candidates
POLOXAMER 188POLOXAMER 188LQA7B6G8JGSOLUTION / OPHTHALMIC0.1 %w/vExact identifier — unii+dosage form
6 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / TOPICAL0.23 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLOXAMER 188POLOXAMER 188LQA7B6G8JGSOLUTION / ORAL1800 mgExact identifier — unii+dosage form
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntisepticBENZETHONIUM CHLORIDEMPM Medical, LLC3f660269-f83d-4f71-9a70-e2ddb2c57ec62025-12-29WarningsExact identifier
ndc (package): 66977-032-08
ndc (product): 66977-032
ndc11 (package): 66977003208
spl id: 471c8cbc-1bec-3105-e063-6394a90a3cd3
spl set id: 3f660269-f83d-4f71-9a70-e2ddb2c57ec6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.