FDA.reportPublic FDA data

Bio-Groom

Manufacturer
Bio-Derm Laboratories Inc.
Effective date
2011-06-10
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:39:24

Label at a glance#

ProductBio-Groom Ear-Care
Active ingredientBORIC ACID, SALICYLIC ACID
Label structure8 sections

Indications and uses

to routinely remove dirt and dissolve ear wax buildup.

Dosage and administration

shake well apply generously to each ear. Gently massage ears until dirt and wax are dissolved. Allow pet to shake its head to dispel accumulation and swab ears with cotton. For best results, use twice a month or after each bath and before and after swimming or as directed by a veterinarian.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Boric acid 0.80%Antibacterial
Salicylic acid 0.20%Antiseptic ear cleaner

Uses

INDICATIONS & USAGE SECTION

to routinely remove dirt and dissolve ear wax buildup.

Warnings

WARNINGS SECTION

For external use only on dogs and cats

Ask a veterinarian before use if your pet has

OTC - ASK DOCTOR SECTION

  • painful ear condition
  • discharge
  • broken or abraded skin

When Using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a veterinarian if

OTC - STOP USE SECTION

  • condition worsens or does not improve after use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • apply generously to each ear. Gently massage ears until dirt and wax are dissolved.
  • Allow pet to shake its head to dispel accumulation and swab ears with cotton.
  • For best results, use twice a month or after each bath and before and after swimming or as directed by a veterinarian.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, isopropyl alcohol, polysorbate 60, eucalyptol.

SPL UNCLASSIFIED SECTION

Manufactured by
bio-derm®
LABORATORIES, INC.
P.O.BOX 8070,
LONGVIEW, TX 75607 USA

PRINCIPAL DISPLAY PANEL - 3.8L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIO-GROOM®

EAR-CARE™
NON-OILY NON-STICKY

EAR
CLEANER

Gently cleans and dries the ear
canal. Removes excessive
wax build-up.

PRINCIPAL DISPLAY PANEL - 3.8L Bottle Label
PRINCIPAL DISPLAY PANEL - 3.8L Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46521-003-01Bio-Groom Ear-Care29 mL in 1 BOTTLESOLUTION291
46521-003-04Bio-Groom Ear-Care118 mL in 1 BOTTLESOLUTION1181
46521-003-08Bio-Groom Ear-Care236 mL in 1 BOTTLESOLUTION2361
46521-003-28Bio-Groom Ear-Care3800 mL in 1 BOTTLESOLUTION38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46521-003BIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]14 package rows20110803_39e164d2-84f2-4bfc-be0d-3876a6e5c66a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BORIC ACIDACTIVE INGREDIENTR57ZHV85D41
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
BORIC ACIDACTIVE MOIETYR57ZHV85D41
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TK1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46521-00346521-003-04, 46521-003-08, 46521-003-01, 46521-003-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4ACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLYSORBATE 60CAL22UVI4MIACT
EUCALYPTOLRV6J6604TKIACT

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 · 29 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKSOLUTION / NASAL0.2 mg/1mlExact identifier — unii candidate
7 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKDROPS / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKSOLUTION / DENTALNAExact identifier — unii candidate
7 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / VAGINAL0.03 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii candidate
13 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKPASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKJELLY / NASAL68.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKCAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKDROPS / NASAL0.2 mg/1mlExact identifier — unii candidate
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 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
V-BellaBORIC ACIDU.S. PHARMACEUTICAL CORPORATION3c3a423c-805d-4146-b16e-0138617a8dc62022-11-17WarningsName fallback
generic name: BORIC ACID

Reported adverse events (FAERS/openFDA)#

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