1. Home
  2. Labeler Index
  3. Chattem, Inc.
  4. 41167-0088
  5. Label Information: Icy Hot Pain Relieving Cream

FDA Label for Icy Hot Pain Relieving Cream

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. PRINCIPAL DISPLAY PANEL

Icy Hot Pain Relieving Cream Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. 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 Ingredient



Menthol 10%

Methyl salicylate 30%

Menthol 7.6%

Methyl salicylate 29%

Menthol 10%

Methyl salicylate 30%


Purpose



Topical analgesic

Topical analgesic

Topical analgesic


Uses



temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

    • temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps

      • temporarily relieves minor pain associated with:

      • arthritis
      • simple backache
      • muscle strains
      • sprains
      • bruises
      • cramps

Warnings



For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

For external use only

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

For external use only

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.


When Using This Product



  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
    • use only as directed
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly or use with a heating pad
    • do not apply to wounds or damaged, broken or irritated skin
      • use only as directed
      • do not bandage tightly or use with a heating pad
      • avoid contact with eyes or mucous membranes
      • do not apply to wounds or damaged, broken or irritated skin

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
    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
      • condition worsens
      • symptoms persist for more than 7 days or clear up and occur again within a few days
      • redness is present
      • irritation develops

If Pregnant Or Breast-Feeding,



ask a health care professional before use.

ask a health care professional before use.

ask a health care professional before use.


Keep Out Of Reach Of Children.



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

If case of accidental ingestion, get medical help or contact a Poison Control Center right away.

continued on cap

If case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Directions



adults and children over 12 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but not more than 4 times daily

    • children 12 years or younger: ask a doctor

    adults and children over 12 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but not more than 4 times daily

      • children 12 years or younger: ask a doctor

      adults and children over 12 years:

      • apply generously to affected area
      • massage into painful area until thoroughly absorbed into skin
      • repeat as necessary, but not more than 4 times daily

        • children 12 years or younger: ask a doctor


Inactive Ingredients



ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)





ICYHOT® PAIN RELIEVING BALM
Drug Facts

paraffin, white petrolatum (245-109)




ICYHOT® PAIN RELIEVING CREAM
Drug Facts

carbomer, cetyl esters, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water (245-110)

Close cap tightly after use.






Principal Display Panel



ICYHOT® PAIN RELIEVING STICK
EXTRA STRENGTH
PAIN RELIEVING STICK
Net wt 1.75 oz (49 g)

PRINCIPAL DISPLAY PANELICYHOT® PAIN RELIEVING STICKEXTRA STRENGTHNet wt 1.75 oz (49 g) - icy hot 01

PRINCIPAL DISPLAY PANELICYHOT® PAIN RELIEVING STICKEXTRA STRENGTHNet wt 1.75 oz (49 g) - icy hot 01

ICYHOT® PAIN RELIEVING BALM
EXTRA STRENGTH
Net wt 3.5 oz (99.2 g)

ICYHOT® PAIN RELIEVING CREAM
Net wt 1.25 oz (35.4 g)
EXTRA STRENGTH


* Please review the disclaimer below.