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| Product NDC Code | 62168-0228 | ||||
|---|---|---|---|---|---|
| Drug Name | Icy hot kids pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Lead Chemical Co., Ltd. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions children 5 years of age and older: ▪ patch may be cut into smaller sizes with scissors prior to removal of the backing ▪ 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 5 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves minor aches and pains of muscles and joints associated with: ▪ arthritis ▪ simple backache ▪ strains ▪ sprains ▪ bruises
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Icy Hot Kids Pain Relief Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM GLYCERIN ISOPROPYL MYRISTATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE TALC TARTARIC ACID TITANIUM DIOXIDE WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel – Pouch Label ICY HOT ® KIDS PAIN RELIEF PATCH FAST ACTING EASY TO APPLY AND REMOVE WEAR UP TO 8 HOURS WITH NATURALLY-SOURCED MENTHOL 5% DEVELOPED WITH PEDIATRICIANS AGES 5+ CONTAINS 5 PATCHES IN ONE RESEALABLE POUCH 3-1/8" x 4-5/8" (8 cm x 12 cm) EACH PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2022 www.icyhot.com Label image-01
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ▪ on wounds or on irritated or damaged skin ▪ with a heating pad
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ▪ 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 ▪ your child experiences severe burning pain, swelling, or blistering where the product was applied
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ▪ 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use ▪ on wounds or on irritated or damaged skin ▪ with a heating pad When using this product ▪ 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 ▪ 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 ▪ your child experiences severe burning pain, swelling, or blistering where the product was applied 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API