Active Ingredient
Menthol 5%
Cold And Hot Medicated Large Patch
FDA Label NDC 52000-421
9 label sections · Submitted to the FDA by Universal Distribution Center Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Cold And Hot Medicated Large (NDC 52000-421). 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, uses, warnings:, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Temporarily relieve minor aches and pains of muscles and joints due to
• simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • cramps
Warnings:
EXTERNAL USE ONLY
When using this product
• USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.
STOP USE and ask a doctor if
• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops
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) immediately.
Directions
Adults and Children 12 years of age and older:
• Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 to 4 times daily
Children under 12 years of age: Consult a doctor.
Other Information
• store at room temperature 68° to 77°F (20° to 25°C)
Inactive Ingredients
Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Packaging
Cold And Hot Medicated Large (52000421 1)
* Please review the disclaimer below.
