Label: ICY HOT MEDICATED- menthol patch
ICY HOT MEDICATED, BACK- menthol patch
ICY HOT MEDICATED, XL- menthol patch
ICY HOT MEDICATED, ADVANCED RELIEF- menthol patch
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NDC Code(s):
62168-0084-3,
62168-0084-4,
62168-0805-4,
62168-0843-9, view more62168-0847-3, 62168-0847-4, 62168-0847-5, 62168-0847-6, 62168-0847-7
- Packager: Lead Chemical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 4, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
-
Uses
Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches
temporarily relieves minor pain associated with:
- ▪
- arthritis
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- simple backache
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- bursitis
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- tendonitis
- ▪
- muscle strains
- ▪
- sprains
- ▪
- bruises
- ▪
- cramps
Icy Hot Advanced Relief Patches
temporarily relieves minor aches and pains of muscles and joints associated with:
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- arthritis
- ▪
- simple backache
- ▪
- strains
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- sprains
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- bruises
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Warnings
For external use only
Do not use
Icy Hot Advanced Relief Patches
- ▪
- on wounds or on irritated or damaged skin
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- with a heating pad
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.
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- avoid contact with eyes and mucous membranes
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- rare cases of serious burns have been reported with products of this type
- ▪
- do not apply to wounds or damaged, broken or irritated skin
- ▪
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
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- a transient burning sensation may occur upon application but generally disappears in several days
Icy Hot Advanced Relief Patches
- ▪
- use only as directed
- ▪
- do not bandage tightly
- ▪
- avoid contact with eyes and mucous membranes
- ▪
- do not expose the area to local heat or to direct sunlight
- ▪
- rare cases of serious burns have been reported with products of this type
- ▪
- a transient burning sensation may occur upon application but generally disappears in several days
- ▪
- avoid applying into skin folds
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
Icy Hot Advanced Relief Patches
- ▪
- condition worsens or symptoms persist for more than 7 days
- ▪
- symptoms clear up and occur again within a few days
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- redness is present or excessive skin irritation occurs
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- you experience severe burning pain, swelling, or blistering where the product was applied
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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
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- carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
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- once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
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- wear one Icy Hot patch for up to 8 hours
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- repeat as necessary, but no more than 3 times daily
children 12 years or younger: ask a doctor
Icy Hot Advanced Relief Patches
adults and children 12 years of age and older:
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- clean and dry affected area
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- gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.
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- remove remaining film backing from both sides and finish applying to skin
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- apply to affected area not more than 3 to 4 times daily
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- wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.
children under 12 years of age: ask a doctor
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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, mineral oil, polyisobutene, styrene/isoprene copolymer
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Principal Display Panel - Arm, Neck & Leg Pouch
MENTHOL 5%
ICY HOT®
ORIGINAL
Pain Relief PatchARM, NECK & LEG
PATCHFEEL IT
WORKING
INSTANTLY- ➢
- Powerful Targeted Relief
- ➢
- Icy to Dull, Hot to Relax
- ➢
- Comfortable Fabric
- ➢
- Stays in Place
Wear For Up To 8 Hours
Contains 5 Patches in 1 Resealable Pouch
3-1/8" x 4-5/8" (8 cm x 12 cm) each
CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020 www.icyhot.comPouch Label - Arm, Neck, & Leg
-
Principal Display Panel – Extra Strength Back and Large Areas
ICY HOT®
MEDICATED
PATCH
Menthol 5%BONUS
20%
MORE! one free
patch insideTARGETED
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 PadEXTRA STRENGTH
BACK
and Large AreasContains 6 Patches in 1 Resealable Pouch
3-15/16” x 7-13/16” (10 cm x 20 cm) each
CHATTEM®
A SANOFI COMPANY
Distributed by Chattem, Inc., P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2017 www.icyhot.comPouch Label - Back and Large Areas – Bonus
-
Principal Display Panel - XL Back
MENTHOL 5%
ICY HOT®
ORIGINAL
Pain Relief PatchXL PATCH
FEEL IT
WORKING
INSTANTLY- ➢
- Powerful Targeted Relief
- ➢
- Icy to Dull, Hot to Relax
- ➢
- Comfortable Fabric
- ➢
- Stays in Place
Wear For Up To 8 Hours
Contains 3 Patches in 1 Resealable Pouch
5-1/2" x 9-3/4" (14 cm x 25 cm) each
CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020 www.icyhot.comPouch Label - XL Back
-
Principal Display Panel - Extra Strength XL Back and Large Areas
MENTHOL 5%
ICY HOT®
ORIGINAL
Pain Relief PatchXL PATCH
FEEL IT
WORKING
INSTANTLY- ➢
- Powerful Targeted Relief
- ➢
- Icy to Dull, Hot to Relax
- ➢
- Comfortable Fabric
- ➢
- Stays in Place
Wear For Up To 8 Hours
Contains 4 Patches in 1 Resealable Pouch
5-1/2" x 9-3/4" (14 cm x 25 cm) each
CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020 www.icyhot.comPouch Label - XL Back – Bonus
-
Principal Display Panel - Advanced Pain Relief Patch
MENTHOL 7.5%
ICY HOT®
ADVANCED
Pain Relief PatchLARGE PATCH
MORE PAIN FIGHTING INGREDIENTS*- ➢
- Fast Acting Powerful Relief
- ➢
- Comfortable Fabric
- ➢
- Stays in Place
Wear For Up To 8 Hours
Contains 5 Patches in 1 Resealable Pouch
3-15/16" x 5-1/2" (10 cm x 14 cm) each*Per same size patch vs Icy Hot®
original strength patch
Dist. by: Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2021 www.icyhot.comPouch Label - Advanced Pain Relief Patch
-
INGREDIENTS AND APPEARANCE
ICY HOT MEDICATED
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0084 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 205.5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62168-0084-3 270 in 1 BOX 06/09/2021 06/30/2026 1 5 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:62168-0084-4 160 in 1 CARTON 12/08/2023 2 5 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 11/01/2000 ICY HOT MEDICATED, BACK
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0843 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 428.5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62168-0843-9 80 in 1 CARTON 10/16/2017 03/31/2024 1 6 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 03/01/2003 03/31/2024 ICY HOT MEDICATED, XL
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0847 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 750 mg Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62168-0847-4 100 in 1 BOX 06/01/2011 03/31/2024 1 NDC:62168-0847-3 4 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:62168-0847-5 120 in 1 CARTON 05/17/2021 07/31/2026 2 3 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:62168-0847-6 100 in 1 BOX 05/12/2021 01/31/2025 3 4 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:62168-0847-7 100 in 1 CARTON 09/19/2023 4 3 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 12/01/2007 ICY HOT MEDICATED, ADVANCED RELIEF
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0805 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 210 mg Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62168-0805-4 300 in 1 BOX 07/05/2021 03/31/2024 1 5 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 12/01/2012 03/31/2024 Labeler - Lead Chemical Co., Ltd. (693727091)