Otc - Active Ingredient
Active ingredient..................................Purpose
Methol 5%................................Topical Analgesic
Winco Cold And Hot Medicated Patch Large Patch
FDA Label NDC 67091-914
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Cold And Hot Medicated Patch Large (NDC 67091-914). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
temporarily relieves minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
Warnings
For external use only
Otc - Do Not Use
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you have
- redness over the affected area
Otc - When Using
When using this product
- use only as directed
- avoid contact with eyes or mucous membranes
- do not bandage tightly
- discontiue use at least 1 hour before a bath or shower
- do not use immedialtely after a bath or shower
Otc - Stop Use
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
- excessive skin irritation occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
-open pouch and remove patch
-carefully peel off protective backing and apply sticky side to affected area
-adults and children 12 years of age and older:
- do not wear patch for more than 8 hours
- apply to affected area no more than 3 times daily
-children under 12 years of age: consult a doctor
Storage And Handling
Other Information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide
Dosage & Administration
Distributed By:
WINCO FOODS, LLC,
BOISE, ID 83704
MADE IN CHINA
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