BIO-ICE- menthol, camphor gel

BIO-ICE by

Drug Labeling and Warnings

BIO-ICE by is a Otc medication manufactured, distributed, or labeled by Electrostim Medical Services Inc. d/b/a EMSI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

MENTHOL 5.4%

CAMPHOR 0.48%

PURPOSE

PURPOSE

TOPICAL ANALGESIC

COUNTER IRRITANT

INDICATIONS & USAGE

USES: TEMPORARY RELIEF OF

• ARTHRITIS
• BACKACHE
• STRAINS
• SPRAINS

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY.

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.

STOP USE

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIO-ICE 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50130-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.4 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.48 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
UNCARIA TOMENTOSA LEAF (UNII: 487U8M3D2P)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
CAMPHOR OIL (UNII: 75IZZ8Y727)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50130-316-11	88.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2013

Labeler - Electrostim Medical Services Inc. d/b/a EMSI (932471881)