FDA Label for Hot And Cold With Lidocaine-careone Pain Relieving

View Indications, Usage & Precautions

Hot And Cold With Lidocaine-careone Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Yash Pharmaceuticals. 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.

Drug Facts



HOT AND COLD CREAM with LIDOCAINE-RA
PAIN RELIEVING CREAM
Drug Facts


Active Ingredients



Lidocaine HCl 4%
Menthol 1%


Purposes



Lidocaine- Topical anesthetic,
Menthol- Topical Analgesic


Warnings



For external use only


Do Not Use



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

When Using Section



  • Use only as directed. Read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
  • avoid contact with eyes and mucous membranes
  • a transient burning sensation may occur upon application but generally disappears in several days

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children Section



Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
  • children 12 years or younger: ask a doctor


Inactive Ingredient Section



Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly
Keep Carton As It Contains Important Information
Close cap tightly between uses.


Outer Label



Temporarily relieves minor pain


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