FDA.reportPublic FDA data

BIO-ICE

Manufacturer
Electrostim Medical Services Inc. d/b/a EMSI
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:27:40

Label at a glance#

ProductBIO-ICE
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

MENTHOL 5.4%

CAMPHOR 0.48%

OTC - PURPOSE SECTION

PURPOSE

TOPICAL ANALGESIC

COUNTER IRRITANT

INDICATIONS & USAGE SECTION

USES: TEMPORARY RELIEF OF

  • ARTHRITIS
  • BACKACHE
  • STRAINS
  • SPRAINS

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY.

OTC - DO NOT USE SECTION

DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.

DO NOT USE WITH HEATING PADS OR DEVICES, OR UNDER BANDAGE.

DO NOT USE IF PREGNANT OR BREAST FEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.

DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.
  • RUB IN THOROUGHLY UNTIL GEL IS ABSORBED.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

WATER, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT, HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT, BOSWELLIA SERRATA EXTRACT, CAMPHOR FOR SCENT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bio-Ice_LBLBio-Ice_LBL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372902camphor 0.48 % / menthol 5.4 % Topical GelPSN8
1372902camphor 0.0048 MG/MG / menthol 0.054 MG/MG Topical GelSCD8
1372902camphor 0.48 % / menthol 5.4 % Topical GelSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50130-316-112023-10-20C16284748780-1ab0e2407-3548-f274-e053-dbdaa90a6471BIO-ICE
50130-316-112022-01-28C16284748780-1ab0e2407-3548-f274-e053-dbdaa90a6471BIO-ICE
50130-316-112020-12-31C16284748780-1ab0e2407-3548-f274-e053-dbdaa90a6471BIO-ICE
50130-316-112020-09-27C16284748780-1ab0e2407-3548-f274-e053-dbdaa90a6471BIO-ICE
50130-316-112020-09-25C16284748780-1ab0e2407-3548-f274-e053-dbdaa90a6471BIO-ICE
50130-316-112020-07-22C16284748780-1ab0e2407-3548-f274-e053-dbdaa90a6471BIO-ICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50130-316-11BIO-ICE88.8 mL in 1 BOTTLEGEL88.88

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
MENTHOLACTIVE MOIETYL7T10EIP3A1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q1
BOSWELLIA SERRATA RESIN OILINACTIVE INGREDIENT5T1XCE6K8K1
CAMPHOR OILINACTIVE INGREDIENT75IZZ8Y7271
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P91
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4F1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
UNCARIA TOMENTOSA LEAFINACTIVE INGREDIENT487U8M3D2P1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50130-31650130-316-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
HYDRATED SILICAY6O7T4G8P9IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
METHYLPARABENA2I8C7HI9TIACT
UNCARIA TOMENTOSA LEAF487U8M3D2PIACT
BOSWELLIA SERRATA RESIN OIL5T1XCE6K8KIACT
CAMPHOR OIL75IZZ8Y727IACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii+route
4 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii+route
4 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii+route
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii+route
4 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
BIO-ICEMENTHOL, CAMPHORElectrostim Medical Services Inc. d/b/a EMSI1bfd1468-9139-43b1-9709-d47b63d17cfb2025-12-18WarningsExact identifier
ndc (package): 50130-316-11
ndc (product): 50130-316
ndc11 (package): 50130031611
spl id: 463d9205-8ccc-8c5c-e063-6394a90a47c5
spl set id: 1bfd1468-9139-43b1-9709-d47b63d17cfb

Reported adverse events (FAERS/openFDA)#

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