Icy Hot Back And Large Areas Patch
FDA Label NDC 41167-0073

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 Back And Large Areas (NDC 41167-0073). 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

→ 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.

→ Directions

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- 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 and mucous membranes
do not apply to wounds or damaged skin, broken or irritated skin

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

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

remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
apply one patch to affected area
wear one Icy Hot Patch up to 8 hours
repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor

adults and children over 12 years.

remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
carefully remove backing from patch
apply one patch to affected area
wear one Icy Hot Patch up to 8 hours
repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor

adults and children over 12 years.

remove backing from patch by grasping both ends firmly and gently pulling until backing separates
carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
apply one patch to affected area
wear one Icy Hot Patch up to 8 hours
repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients

acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT.

Icy Hot® - Medicated Patch

BACK & LARGE AREAS

Visit us on the web at www.icyhot.com Made in Japan

Icy Hot® - Medicated Patch

XL BACK & LARGE AREAS

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT.

Made in Japan. Visit us on the web at www.icyhot.com 0044855-02

Principal Display Panel

EXTRA STRENGTH
ICY HOT^®
MEDICATED PATCH
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away^®
Lasts up to 8 Hours!
Small Patch
3-1/8” x 4-5/8” (8 cm x 12 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
ARM. NECK & LEG
& SMALL AREAS
Contains 5 Patches in 1 Resealable Pouch

Principal Display Panel (Icy Hot Patch 01)

EXTRA STRENGTH
ICY HOT^®
MEDICATED PATCH
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away^®
Lasts up to 8 Hours!
LARGE PATCH
3-15/16” x 7-13/16” (10 cm x 20 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
BACK
& LARGE AREAS
Contains 5 Patches
In 1 Resealable Pouch

Principal Display Panel (Icy Hot Patch 02)

EXTRA STRENGTH
ICY HOT^®
MEDICATED PATCH XL
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away^®
75 % Larger
Than Regular Back Patches
Lasts up to 8 Hours!
EXTRA LARGE PATCH
5-1/2” x 9-3/4” (14 cm x 25 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
XL BACK
& LARGE AREAS
Contains 3 Patches
In 1 Resealable Pouch

Principal Display Panel (Icy Hot Patch 03)

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