Bio-ice Gel
FDA Label NDC 50130-316

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Electrostim Medical Services Inc. D/b/a Emsi for the product Bio-ice (NDC 50130-316). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS

MENTHOL 5.4%

CAMPHOR 0.48%

Otc - Purpose

PURPOSE

TOPICAL ANALGESIC

COUNTER IRRITANT

Indications & Usage

USES: TEMPORARY RELIEF OF

  • ARTHRITIS
  • BACKACHE
  • STRAINS
  • SPRAINS

Warnings

WARNINGS

FOR EXTERNAL USE ONLY.

Otc - Do Not Use

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

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

Otc - Keep Out Of Reach Of Children

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

Dosage & 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.

Inactive Ingredient

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_lbl (Bio Ice Lbl)

Bio-ice_lbl (Bio Ice Lbl)

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