Bio-ice

Bio-ice
SPL v8
SPL
SPL Set ID 1bfd1468-9139-43b1-9709-d47b63d17cfb
Route
TOPICAL
Published
Effective Date 2013-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.4 g) Camphor (synthetic) (0.48 g)
Inactive Ingredients
Water Isopropyl Alcohol Propylene Glycol Glycerin Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Ilex Paraguariensis Leaf Hydrated Silica Aminomethylpropanol Methylparaben Uncaria Tomentosa Leaf Boswellia Serrata Resin Oil Camphor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-01-01
Description

ACTIVE INGREDIENTS MENTHOL 5.4% CAMPHOR 0.48%

Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY.

Indications and Usage

USES: TEMPORARY RELIEF OF

  • ARTHRITIS
  • BACKACHE
  • STRAINS
  • SPRAINS
Dosage and Administration

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.

Description

ACTIVE INGREDIENTS MENTHOL 5.4% CAMPHOR 0.48%

Section 50565-1

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

Section 50566-9

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

Section 50570-1

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.

Section 51727-6

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.

Section 51945-4

Section 55105-1

PURPOSE

TOPICAL ANALGESIC

COUNTER IRRITANT

Section 55106-9

ACTIVE INGREDIENTS

MENTHOL 5.4%

CAMPHOR 0.48%

Structured Label Content

Indications and Usage (34067-9)

USES: TEMPORARY RELIEF OF

  • ARTHRITIS
  • BACKACHE
  • STRAINS
  • SPRAINS
Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

TOPICAL ANALGESIC

COUNTER IRRITANT

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS

MENTHOL 5.4%

CAMPHOR 0.48%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:50.721504 · Updated: 2026-03-14T23:11:44.718615