Icy Hot Vanishing Scent Gel
FDA Label NDC 41167-0092

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 Vanishing Scent (NDC 41167-0092). 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 2.5%

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
  • 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
  • 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.

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 generously to affected area
  • squeeze desired amount of Icy Hot® pain relieving gel onto affected area
  • using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed
  • repeat as necessary, but not more than 4 times daily

    • children 12 years or younger: ask a doctor

Inactive Ingredients

allantoin, aloe barbadensis leaf juice, carbomer, DMDM hydantoin, glycerin, methylparaben, phenoxyethanol, propylparaben, SD alcohol 40-2 (15.47%), steareth-2, steareth-21, triethanolamine, water (245-135)

Keep carton as it contains important information.

Close cap tightly after use.

Principal Display Panel

ICYHOT® VANISHING SCENT PAIN RELIEVING GEL
Menthol 2.5%
Net wt 2.5 oz (70.8 g)

Principal Display Panelicyhot® Vanishing Scent Pain Relieving Gelmenthol 2.5%net Wt 2.5 Oz (70.8 G) (Icy Hot Vanishing Scent 01)

Principal Display Panelicyhot® Vanishing Scent Pain Relieving Gelmenthol 2.5%net Wt 2.5 Oz (70.8 G) (Icy Hot Vanishing Scent 01)

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