Otc - Active Ingredient
Active Ingredients Purposes
Camphor 1.2%...................Topical analgesic
Menthol 5.7%.....................Topical analgesic
Methyl salicylate 6.3%.......Topical analgesic
Coralite Muscle And Joint Pain Relief Patch
FDA Label NDC 65923-148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corporation for the product Coralite Muscle And Joint Pain Relief (NDC 65923-148). 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 the minor aches and pains of muscles and joints associated with:
- sprains
- simple backache
- arthritis
- strains
- bruises
Warnings
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Otc - Do Not Use
Do not use
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
- 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
- do not use otherwise than as directed
- avoid contact with eyes, mucous membranes or rashes
- do not bandage tightly
- discontinue use at least 1 hour before a bath or shower
- do not use immediately after a bath or shower
Otc - Stop Use
Stop use and ask a doctor if
- redness is present or irritation or rash develops
- conditioin worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
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:
- clean and dry affected area
- apply to affected area no more than3 times daily
- do not wear patch for more than 8 hours
- children under 12 years of age: consult a doctor
Storage And Handling
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients lanolin, natural rubber, petrolatum, polyisobutylene, rosin, zinc oxide
Otc - Questions
Call 1-800-814-8028 Monday-Friday 9AM-5PM (PST)
Dosage & Administration
Distributed By:
UNITED EXCHANGE CORP.
5836 Corporate Ave.
Cypress, CA. 90630 USA
1-800-814-8028
Made in China
* Please review the disclaimer below.
