Hygienic Ear Care Antiseptic

Manufacturer
The Richline Group, Inc.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:20

Label at a glance#

ProductHygienic Ear Care Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12% w/w

Purpose

OTC - PURPOSE SECTION

Ear Care Antiseptic

Use

INDICATIONS & USAGE SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Stop use and ask a doctor

OTC - STOP USE SECTION

if you experience pain, redenss, or swelling.

Directions

DOSAGE & ADMINISTRATION SECTION

For optimal results, follow these steps everday.

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water

Questions?

OTC - QUESTIONS SECTION

Call 1-800-255-8556

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4OZLabel4OZLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052949benzalkonium chloride 0.12 % Topical SolutionPSN3
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCD3
1052949benzalkonium chloride 0.12 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70094-001-04Hygienic Ear Care Antiseptic118 mL in 1 BOTTLESOLUTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70094-001HYGIENIC EAR CARE ANTISEPTIC (BENZALKONIUM CHLORIDE) SOLUTION [THE RICHLINE GROUP, INC.]3Current NDC, Legacy NDC, 1 package rows20231108_98b70f22-cd53-e61b-e053-2995a90a730d.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
70094-00170094-001-04

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
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
ndc (package): 70094-001-04
ndc (product): 70094-001
ndc11 (package): 70094000104
spl id: 098688fd-eb21-29d6-e063-6294a90ade41
spl set id: 98b70f22-cd53-e61b-e053-2995a90a730d

Reported adverse events (FAERS/openFDA)#

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