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  5. Label Information: Hot And Cold With Lidocaine Pain Relieving

FDA Label for Hot And Cold With Lidocaine Pain Relieving

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSES
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN AND PETS.
    11. DIRECTIONS
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL

Hot And Cold With Lidocaine Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Velocity Pharma Llc. 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

PAIN RELIEVING CREAM

Drug Facts


Active Ingredients



Lidocaine HCl 4%

Menthol 1%


Purposes



Lidocaine- Topical anesthetic,

Menthol- Topical Analgesic


Uses



Temporarily relieves minor pain


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 This Product



  • 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

Stop Use And Ask A Doctor If



  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children And Pets.



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


Directions



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 Ingredients



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.


Principal Display Panel



Hot and cold Cream
Lidocaine
Plus Menthol
Pain Relieving Cream
Net Wt 2.7 OZ (76.5 g)

Hot and cold Cream
Lidocaine
Plus Menthol
Pain Relieving Cream
Net Wt 1 OZ (28.35 g)


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