Active Ingredient
Menthol 5.00%.
Cold Hot Patch
FDA Label NDC 62379-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Simple Diagnostics, Inc. for the product Cold Hot Patch (NDC 62379-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnning, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Use
temporarily relieves minor aches and pains of muscles and joints due to
.arthritis .simple backache .strains . sprains
.bursitis .tendonitis . Bruises . Cramps
Warnning
For external use only.
When using this product.use only as directed . avoid contact with eyes and mucous membranes. do not apply to wounds or damaged skin.do not bandage tightly or use a heating pad
Stop use and ask doctor if
.excessive redness or irritation is present
.condition worsens
.pain persist for more than 7 days
.symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use, keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.
Otc - Keep Out Of Reach Of Children
keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.
Directions
.adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
.children under 12 years: ask a doctor
. for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates.
Remove protective film while applying pad directly to site of pain.
Inactive Ingredients
Acrylic Acid,Aluminum Hydroxide,Carmellose Sodium,2 Ethylhexyl Acrylate,Glycerin,Isopropyl Myristate,Methyl Acrylate,Nonoxynol 30,
Polyacrylate,Polyacrylic Acid,Polysorbate 80,Sorbitan Sesquioleate,Starch,Talc,Tartaric Acid,Titanium Dioxide,Water
Package Label.Principal Display Panel
Image Description (Label1)
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