FDA.reportPublic FDA data

Inverness EAR CARE ANTISEPTIC

Manufacturer
The Richline Group
Effective date
2025-02-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:55:35

Label at a glance#

ProductInverness EAR CARE ANTISEPTIC
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

For optimal results, follow these steps every day: Clean hands thoroughly with antibacterial soap before touching ears and earrings. Using cotton swab, cleanse front and back of ears 3 times a day with Ear Care Antiseptic. Gently rotate the earrings 2 or 3 times a day. DO NOT remove earrings. Keep hair, hair spray, shampoo, soap, cosmetics, perfume, etc. away from newly pierced ears. After shampooing, exercising, ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12% w/w

Purpose

OTC - PURPOSE SECTION

Ear Care Antiseptic

INDICATIONS & USAGE SECTION

Use for care of your pierced ears

Warnings

WARNINGS SECTION

  • For external use only.
  • Do not ingest.
  • If swallowed, get medical help or contact Poison Control Center immediately.
  • In case of contact with eyes, flush with water.

SEEK MEDICAL ATTENTION IF IRRITATION PERSISTS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • Pain, redness, or swelling is not a normal result of ear piercing.
  • Call your doctor if any type of discomfort occurs.
  • Remove earrings immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

For optimal results, follow these steps every day:

  • Clean hands thoroughly with antibacterial soap before touching ears and earrings.
  • Using cotton swab, cleanse front and back of ears 3 times a day with Ear Care Antiseptic. Gently rotate the earrings 2 or 3 times a day. DO NOT remove earrings.
  • Keep hair, hair spray, shampoo, soap, cosmetics, perfume, etc. away from newly pierced ears. After shampooing, exercising, swimming, hot tubs, or use of any of the above products, rinse your ears in clear water and reapply Ear Care Antiseptic, (step 2), to your ears.

Other Information

OTHER SAFETY INFORMATION

EAR LOBE PIERCING

  • Leave earrings in your ears for 6 weeks.
  • After 6 weeks the earrings may be removed; however, some type of post earring must be worn at all time during the first 6 months.

EAR CARTILAGE PIERCING

  • Leave earrings in your ears for 12 weeks.
  • After 12 weeks the earrings may be removed; however, some type of post earring must be worn at all times during the first year.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Purified water.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-255-8556

Representative Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label
KIT
KIT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052949benzalkonium chloride 0.12 % Topical SolutionPSN7
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCD7
1052949benzalkonium chloride 0.12 % Topical SolutionSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70094-010-022020-01-31C16284748780-19d75b9cf-dd09-f424-e053-dadaa90a57ceInverness EAR CARE ANTISEPTIC
70094-010-042020-01-31C16284748780-19d75b9cf-dd09-f424-e053-dadaa90a57ceInverness EAR CARE ANTISEPTIC
70094-010-082020-01-31C16284748780-19d75b9cf-dd09-f424-e053-dadaa90a57ceInverness EAR CARE ANTISEPTIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70094-010-02Inverness EAR CARE ANTISEPTIC60 mL in 1 BOTTLESOLUTION607
70094-010-04Inverness EAR CARE ANTISEPTIC118 mL in 1 BOTTLESOLUTION1187
70094-010-08Inverness EAR CARE ANTISEPTIC236 mL in 1 BOTTLESOLUTION2367

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70094-010INVERNESS EAR CARE ANTISEPTIC (BENZALKONIUM CHLORIDE) SOLUTION [THE RICHLINE GROUP]7Current NDC, 3 package rows20250221_ac42d2f1-69e3-45f6-8002-d45ebed5ee22.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70094-01070094-010-04, 70094-010-02, 70094-010-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

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
Inverness EAR CARE ANTISEPTICBENZALKONIUM CHLORIDEThe Richline Groupac42d2f1-69e3-45f6-8002-d45ebed5ee222025-02-17WarningsExact identifier
ndc (package): 70094-010-04
ndc (package): 70094-010-02
ndc (package): 70094-010-08
ndc (product): 70094-010
ndc11 (package): 70094001008
ndc11 (package): 70094001004
ndc11 (package): 70094001002
spl id: 2e5ccc2b-87f0-e1ca-e063-6294a90a6ac1
spl set id: ac42d2f1-69e3-45f6-8002-d45ebed5ee22

Reported adverse events (FAERS/openFDA)#

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