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THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON

Medically reviewed on May 29, 2018

Dosage form: gel
Ingredients: MENTHOL 3.9g in 100mL
Labeler: APEX-CAREX HEATHCARE PRODUCTS
NDC Code: 69851-101

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

NATURAL MENTHOL 3.9%

PURPOSE

COOLING PAIN RELIEF

USES

TEMPORARY RELIEF OF

  • ARTHRITIS
  • BACKACHE
  • STRAINS/SPRAINS

WARNINGS

FOR EXTERNAL USE ONLY.

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

DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGES.

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

DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

KEEP OUT OF REACH OF CHILDREN.

IF ACCIDENTALLY INGESTED, SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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 INGREDIENTS

WATER, SD ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT (YERBA MATE), HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT (CAT'S CLAW), BOSWELIA SERRATA EXTRACT, CAMPHOR FOR SCENT

THERAPEUTIC ICY COLD  COOLING PAIN RELIEF ROLL-ON
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69851-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
PROPYLENE GLYCOL 
GLYCERIN 
CARBOMER 940 
ILEX PARAGUARIENSIS LEAF 
HYDRATED SILICA 
AMINOMETHYLPROPANOL 
METHYLPARABEN 
UNCARIA TOMENTOSA LEAF 
BOSWELLIA SERRATA RESIN OIL 
CAMPHOR OIL 
Packaging
#Item CodePackage Description
1NDC:69851-101-1388.8 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/15/2015
Labeler - APEX-CAREX HEATHCARE PRODUCTS (622368947)

 
APEX-CAREX HEATHCARE PRODUCTS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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