FDA Label for Mentholatum Lidocaine Heat

View Indications, Usage & Precautions

Mentholatum Lidocaine Heat Product Label

The following document was submitted to the FDA by the labeler of this product The Mentholatum Company. 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.

Active Ingredients



Lidocaine HCl 4%


Purpose



Lidocaine - Topical anesthetic


Uses



temporarily relieves minor pain


Warnings



For external use only


Do Not Use



  • •on large areas of the body or on cut, irritated or blistered skin
  • •on puncture wounds
  • •for more than one week without consulting a doctor

When Using This Product



  • •use only as directed
  • •do not get into eyes
  • •do not bandage tightly or apply external heat to the area of use

Stop Use And Ask A Doctor If



  • •condition worsens
  • •symptoms persist for more than 7 days or clear up and occur again within a few days
  • •redness, rash, or irritation occurs

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • •adults and children 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • •children under 12 years: ask a doctor

Inactive Ingredients



acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, glycerin, glyceryl monostearate, phenoxyethanol, polysorbate 20, purified water, steareth-21, vanillyl butyl ether


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