Icy Hot
FDA Label NDC 44014-086

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nichiban Company Limited for the product Icy Hot (NDC 44014-086). 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 7.5%

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
  • do not overwrap or wrap strips over themselves
  • do not wrap around neck
  • do not apply over large areas of the body or apply in strips longer than 6 inches
  • avoid contact with eyes and 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

If Pregnant Or 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:

  • tear or cut roll to desired size
  • carefully remove backing from one end of strip and place on affected area
  • remove remaining backing and press into place
  • wear Icy Hot Medicated Roll for up to 8 hours
  • repeat as necessary, but no more than 3 to 4 times daily

    • children 12 years or younger: ask a doctor

Other

Keep carton as it contains important information for usage of this product.

Distributed by Chattem, Inc.

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

© 2009 www.icyhot.com

MADE IN JAPAN
[NDC Code]

Principal Display Panel - Medium Roll, Pouch

 Reseal Pouch After Opening

ICY HOT® MEDICATED ROLL
Menthol 7.5%

CUSTOMIZED PAIN RELIEF

  • Tear or Cut to Any Length
  • Lasts up to 8 Hours
  • Comfortable, Flexible, Stays in Place

    • EXTRA STRENGTH
    MEDIUM - 2"

    Pain Relieving Ointment on Breathable, Flexible Fabric

    2" x 60" (5 cm x 150 cm)

    Principal Display Panel (Medium Roll Pouch)

    Principal Display Panel (Medium Roll Pouch)

    Medium Roll Pouch

Principal Display Panel - Large Roll, Pouch

Reseal Pouch After Opening

ICY HOT® MEDICATED ROLL
Menthol 7.5%

CUSTOMIZED PAIN RELIEF

  • Tear or Cut to Any Length
  • Lasts up to 8 Hours
  • Comfortable, Flexible, Stays in Place

    • EXTRA STRENGTH
    LARGE - 3"

    Pain Relieving Ointment on Breathable, Flexible Fabric

    3" x 43" (7.5 cm x 110 cm)

    Principal Display Panel (Large Roll Pouch)

    Principal Display Panel (Large Roll Pouch)

    Large Roll Pouch

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