Icy Hot Advanced Relief Cream
FDA Label NDC 41167-0801

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 Advanced Relief (NDC 41167-0801). 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 ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant of 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 Ingredients

Menthol 16%

Camphor 11%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

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

Warnings

For external use only

When Using This Product

  • use only as directed
  • do not bandage tightly or use with a heating pad, or medicated patch
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears within a few 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

If Pregnant Of 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 over 12 years:

  • apply a thin layer to affected area
  • message into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    • Children 12 years and younger: ask a doctor

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer,  allantoin, aloe barbadensis leaf juice, cetyl alcohol, diisopropyl adipate, disodium EDTA, ethoxydiglycol, fragrance, glycerin, glyceryl stearate, menthyl lactate, methylparaben, PEG-150 sterate, pentylene glycol, 4-t-butylcyclohexanol, phenoxyethanol, polysorbate 80, propanediol, SD alcohol (5% w/w), glycine soja (soybean) sterols, steareth-21, stearic acid, triethanolamine, water, xanthan gum (309-018)

Principal Display Panel

ICY HOT®
ADVANCED
PAIN RELIEF CREAM
Net WT 2 OZ (56 g)

Principal Display Panel Icy Hot®advancedpain Relief Creamnet Wt 2 Oz (56 G) (Icy Hot Advanced Relief Cream 01)

Principal Display Panel Icy Hot®advancedpain Relief Creamnet Wt 2 Oz (56 G) (Icy Hot Advanced Relief Cream 01)

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