FDA Label for Bio-ice
View Indications, Usage & Precautions
Bio-ice Product Label
The following document was submitted to the FDA by the labeler of this product Electrostim Medical Services Inc. D/b/a Emsi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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