Drug Labeling and Warnings

Drug Details

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THERAPEUTIC ICY COLD COOLING PAIN RELIEF- menthol gel 
APEX-CAREX HEATHCARE PRODUCTS

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.

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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

ICY COLD Cooling Pain Relief_Topical Gel

THERAPEUTIC ICY COLD  COOLING PAIN RELIEF
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69851-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 940 (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69851-103-34118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/15/2015
Labeler - APEX-CAREX HEATHCARE PRODUCTS (622368947)

Revised: 5/2015
 
APEX-CAREX HEATHCARE PRODUCTS


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