Label: ICY HOT MEDICATED, BACK- menthol patch
- NDC Code(s): 62168-0856-1
- Packager: Lead Chemical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 4, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
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- 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
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- do not apply to wounds or damaged, broken or irritated skin
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- 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
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Directions
adults and children over 12 years:
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- 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
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Inactive ingredients
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
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Principal Display Panel - Large Patch (6 Patch Pouch)
MENTHOL 5%
ICY HOT®
ORIGINAL
Pain Relief PatchLARGE
PATCHFEEL IT WORKING
INSTANTLY- ➢
- Powerful Targeted Relief
- ➢
- Icy to Dull, Hot to Relax
- ➢
- Comfortable Fabric
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- Stays in Place
Wear For Up To 8 Hours
Contains 6 Patches in 1 Resealable Pouch
3-15/16” x 7-13/16” (10 cm x 20 cm) each
CHATTEM®
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020 www.icyhot.com
Made in JapanPouch Label
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INGREDIENTS AND APPEARANCE
ICY HOT MEDICATED, BACK
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0856 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:62168-0856-1 80 in 1 CARTON 03/31/2021 02/28/2025 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) 03/31/2021 02/28/2025 Labeler - Lead Chemical Co., Ltd. (693727091)