Icy Hot
FDA Label NDC 41167-0089

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot (NDC 41167-0089). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panelicyhot® Pain Relieving Balmextra Strengthnet Wt 3.5 Oz (99.2 G) (Icy Hot 02)

Principal Display Panelicyhot® Pain Relieving Balmextra Strengthnet Wt 3.5 Oz (99.2 G) (Icy Hot 02)

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

Principal Display Panelicyhot® Pain Relieving Creamnet Wt 1.25 Oz (35.4 G)extra Strength (Icy Hot 03)

Principal Display Panelicyhot® Pain Relieving Creamnet Wt 1.25 Oz (35.4 G)extra Strength (Icy Hot 03)

* Please review the disclaimer below.