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西药 · 美国药品标签原文

Icy Hot Medicated, Back

MENTHOL

Icy Hot Medicated, Back · Lead Chemical Co., Ltd.。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

Icy Hot Medicated, Back Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED GLYCERIN ISOPROPYL MYRISTATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE TALC TARTARIC ACID TITANIUM DIOXIDE WATER

活性成分 / Active ingredient

Active Ingredient – Single Patch Pouch Menthol 5% Active ingredient – Five Count Patch Pouch Menthol 5%

用途 / Purpose

Purpose – Single Patch Pouch Topical analgesic Purpose – Five Count Patch Pouch Topical analgesic

适应证 / Indications and usage

Uses – Single Patch Pouch temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises Uses – Five Count Patch Pouch temporarily relieves minor pain associated with: • arthritis • simple backache • bursitis • tendonitis • muscle strains • sprains • bruises • cramps

警告 / Warnings

Warnings – Single Patch Pouch For external use only Do not use – Single Patch Pouch • on wounds or on irritated or damaged skin • with a heating pad When using this product – Single Patch Pouch • 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 – Single Patch Pouch • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • redness is present or excessive skin irritation occurs • you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, – Single Patch Pouch ask a health professional before use. Keep out of reach of children. – Single Patch Pouch If swallowed, get medical help or contact a Poison Control Center right away. Warnings – Five Count Patch Pouch For external use only When using this product – Five Count Patch Pouch • use only as directed. Read and follow all directions and warnings on this label. • avoid contact with eyes and mucous membranes • 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 • a transient burning sensation may occur upon application but generally disappears in several days Stop use and ask a doctor if – Five Count Patch Pouch • 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 If pregnant or breast-feeding, – Five Count Patch Pouch ask a health professional before use. Keep out of reach of children. – Five Count Patch Pouch If swallowed, get medical help or contact a Poison Control Center right away.

禁用事项 / Do not use

Do not use – Single Patch Pouch • on wounds or on irritated or damaged skin • with a heating pad

使用中 / When using

When using this product – Single Patch Pouch • 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 When using this product – Five Count Patch Pouch • use only as directed. Read and follow all directions and warnings on this label. • avoid contact with eyes and mucous membranes • 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 • a transient burning sensation may occur upon application but generally disappears in several days

停用事项 / Stop use

Stop use and ask a doctor if – Single Patch Pouch • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • redness is present or excessive skin irritation occurs • you experience severe burning pain, swelling, or blistering where the product was applied Stop use and ask a doctor if – Five Count Patch Pouch • 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

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, – Single Patch Pouch ask a health professional before use. If pregnant or breast-feeding, – Five Count Patch Pouch ask a health professional before use.

儿童安全 / Keep out of reach of children

Keep out of reach of children. – Single Patch Pouch If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children. – Five Count Patch Pouch If swallowed, get medical help or contact a Poison Control Center right away.

用法用量原文 / Dosage and administration

Directions – Single Patch Pouch adults and children 12 years of age and older: • 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 • apply to affected area not more than 3 to 4 times daily • 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 Directions – Five Count Patch Pouch 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 Children 12 years of younger: ask a doctor

辅料 / Inactive ingredients

Inactive ingredients – Single Patch Pouch 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 Inactive ingredients – Five Count Patch Pouch 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

package label principal display panel

Principal Display Panel – Single Patch Pouch Label ICY HOT ® ORIGINAL LARGE PATCH PAIN RELIEF 5% MENTHOL Feel It Work Instantly † Wear up to 8 hours ICE + HEAT THERAPY * 1 PATCH 3-15/16” X 7-13/16” (10 CM X 20 CM) EACH † Refers to cooling sensation. * Refers to cooling/warming sensation. Dist. by: Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219 ©2025 Made in Japan. Label image-04 Principal Display Panel – Five Count Patch Pouch Label MENTHOL 5% ICY HOT ® ORIGINAL Pain Relief Patch LARGE 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 5 Patches in 1 Resealable Pouch 3-15/16” x 7-13/16” (10 cm x 20 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.com Made in Japan. Label image-05b

来源、版本与许可

资料类型
美国药品标签原文
版本
5 / 20260630
获取时间
2026-10-08
许可
openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.
核对原始来源