FDA Label for Icy Hot Medicated, Advanced Relief
View Indications, Usage & Precautions
- 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 - ARM, NECK, & LEG POUCH
- PRINCIPAL DISPLAY PANEL - BACK & LARGE AREAS
- PRINCIPAL DISPLAY PANEL - BACK & LARGE AREAS - SINGLE PATCH
- PRINCIPAL DISPLAY PANEL - XL BACK
- PRINCIPAL DISPLAY PANEL - EXTRA STRENGTH BACK AND LARGE AREAS
- PRINCIPAL DISPLAY PANEL - EXTRA STRENGTH XL BACK AND LARGE AREAS
- PRINCIPAL DISPLAY PANEL – ADVANCED RELIEF
- PRINCIPAL DISPLAY PANEL - ADVANCED RELIEF - BONUS
Icy Hot Medicated, Advanced Relief Product Label
The following document was submitted to the FDA by the labeler of this product Lead Chemical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches
Menthol 5%
Icy Hot Advanced Relief Patches
Menthol 7.5%
Purpose
Topical analgesic
Uses
Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches
temporarily relieves minor pain associated with:
• arthritis• simple backache• bursitis• tendonitis• muscle strains• sprains• bruises• cramps• arthritis• simple backache• muscle strains• sprains• bruises• cramps
Icy Hot Advanced Relief Patches
temporarily relieves minor pain associated with:
Warnings
For external use only
When Using This Product
Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches
• use only as directed. Read and follow all directions and warnings on this label.• rare cases of serious burns have been reported with products of this type• do not bandage tightly or apply local heat (such as heating pads) to the area of use• avoid contact with eyes and mucous membranes• do not apply to wounds or damaged, broken or irritated skin• do not use at the same time as other topical analgesics• 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, broken or irritated skin• do not use at the same time as other topical analgesics
Icy Hot Advanced Relief Patches
Stop Use And Ask A Doctor If
Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches
• condition worsens• redness is present• irritation develops• symptoms persist for more than 7 days or clear up and occur again within a few days• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied• condition worsens• redness is present• irritation develops• symptoms persist for more than 7 days or clear up and occur again within a few days
Icy Hot Advanced Relief Patches
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
Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches
adults and children over 12 years:
• remove backing from patch by firmly grasping both ends 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• wear one Icy Hot Patch for up to 8 hours• repeat as necessary, but no more than 3 times daily• gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.• remove remaining film backing from both sides and finish applying to skin• use 1 patch for up to 12 hours, once a day
children 12 years or younger: ask a doctor
Icy Hot Advanced Relief Patches
adults and children over 12 years:
children 12 years or younger: ask a doctor
Inactive Ingredients
Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches
aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water
Icy Hot Advanced Relief Patches
glyceryl hydrogenated rosinate, hydrated silica, mineral oil, PEG-400, polyisobutene, styrene/isoprene copolymer
Principal Display Panel - Arm, Neck, & Leg Pouch
ICY HOT®
MEDICATED
PATCH
Menthol 5%
TARGETED
NO MESS RELIEF
• Stops Pain at
the Source• Lasts Up to 8 Hours• Comfortable Fabric
Stays in Place
Pain Relieving Ointment
on a Breathable Adhesive Pad
EXTRA STRENGTH
ARM, NECK & LEG
and Small Areas
Contains 5 Patches in 1 Resealable Pouch
3-1/8" x 4-5/8" (8 cm x 12 cm) each
Principal Display Panel - Back & Large Areas
ICY HOT®
MEDICATED
PATCH
Menthol 5%
TARGETED
NO MESS RELIEF
• Stops Pain at
the Source• Lasts up to 8 Hours• Comfortable Fabric
Stays in Place
Pain Relieving Ointment
on a Breathable Adhesive Pad
EXTRA STRENGTH
BACK
and Large Areas
Contains 5 Patches in 1 Resealable Pouch
3-15/16” x 7-13/16” (10 cm x 20 cm) each
Principal Display Panel - Back & Large Areas - Single Patch
ICY HOT®
MEDICATED
PATCH
Menthol 5%
TARGETED
NO MESS RELIEF
• Stops Pain at
the Source• Lasts Up to 8 Hours• Comfortable Fabric
Stays in Place
Pain Relieving Ointment
on a Breathable Adhesive Pad
EXTRA STRENGTH
BACK
and Large Areas
Contains 1 Patch
3-15/16” x 7-13/16” (10 cm x 20 cm)
Principal Display Panel - Xl Back
ICY HOT®
MEDICATED
PATCH XL
Menthol 5%
75% LARGER*
NO MESS RELIEF
• Stops Pain at
the Source• Lasts Up to 8 Hours• Comfortable Fabric
Stays in Place
Pain Relieving Ointment
on a Breathable Adhesive Pad
EXTRA STRENGTH
XL BACK
and Large Areas
Contains 3 Patches in 1 Resealable Pouch
5-1/2" x 9-3/4" (14 cm x 25 cm) each
Principal Display Panel - Extra Strength Back And Large Areas
ICY HOT®
MEDICATED
PATCH
Menthol 5%
BONUS
20%
MORE! one free
patch inside
TARGETED
NO MESS RELIEF
• Stops Pain at
the Source• Lasts up to 8 Hours• Comfortable Fabric
Stays in Place
Pain Relieving Ointment
on a Breathable Adhesive Pad
EXTRA STRENGTH
BACK
and Large Areas
Contains 6 Patches in 1 Resealable Pouch
3-15/16” x 7-13/16” (10 cm x 20 cm) each
Principal Display Panel - Extra Strength Xl Back And Large Areas
ICY HOT®
MEDICATED
PATCH XL
Menthol 5%
BONUS
33%
MORE! one free
patch inside
75% LARGER*
NO MESS RELIEF
• Stops Pain at
the Source• Lasts up to 8 Hours• Comfortable Fabric
Stays in Place
Pain Relieving Ointment
on a Breathable Adhesive Pad
EXTRA STRENGTH
XL BACK
and Large Areas
Contains 4 Patches in 1 Resealable Pouch
5-1/2” x 9-3/4” (14 cm x 25 cm) each
Principal Display Panel – Advanced Relief
ICY HOT®
ADVANCED RELIEF
PAIN RELIEF PATCH
7.5 % Menthol
Advanced Relief at
the Point of Pain
- Ultra Thin, Flexible
Fabric Patch
- Long-Lasting Formula
- Easy to Apply and Remove
Pain Relieving Ointment
on Breathable, Flexible Fabric
Contains 4 Patches in 1 Resealable Pouch
3 15/16" x 5 1/2" (10 cm x 14 cm) each
Principal Display Panel - Advanced Relief - Bonus
ICY HOT®
ADVANCED RELIEF
PAIN RELIEF PATCH
7.5 % Menthol
BONUS
25%
MORE! one free
patch inside
Advanced Relief at
the Point of Pain
- Ultra Thin, Flexible Fabric Patch
- Long-Lasting Formula
- Easy to Apply and Remove
Pain Relieving Ointment
on Breathable, Flexible Fabric
Contains 5 Patches in 1 Resealable Pouch
3 15/16" x 5 1/2" (10 cm x 14 cm) each
* Please review the disclaimer below.
