Otc - Active Ingredient
Active ingredient Purpose
Lidocaine 4%...............................................Topical analgesic
Coralite Odor Free Pain Relief Patch
FDA Label NDC 65923-149
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 Odor Free Pain Relief (NDC 65923-149). 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 - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, 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 pain
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- more than 1 patch on your body at a time or on cut, irritated or swollen skin
- at the same time as other topical analgesics
- on puncture wounds
- for more than one week without consulting a doctor
Otc - When Using
When using this product
- use only as directed. Read and follow all directions and warning on this label.
- do not allow contact with the eyes
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- discontinue use at least 1 hour before a bath or shower
- do not use immediately after a bath or shower
- dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- redness is present
- symptoms persist for more than 7 days or clear up and occur again within a few days
- irritation develops
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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
- adults and children over 12 years:
- clean and dry affected area
- remove backing from patch by firmly grasping both ends and gently pulling until backing seperates 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.
- use 1 patch for up to 12 hours
- children 12 years or younger: ask 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, tartaric acid, titanium dioxide
Otc - Questions
Questions or comments?
Call 1-800-814-8028 Monday-Friday 9AM-5PM (PST)
Dosage & Administration
Distributed By: UNITED EXCHANGE CORPORATION
Cypress, CA 90630 USA | 1-888-645-8204
Made in China
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