Otc - Active Ingredient
Lidocaine 4.0%
Menthol 1.0%
Equate Lidocaine And Menthol Paraben Free Patch
FDA Label NDC 79903-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walmart Stores Inc for the product Equate Lidocaine And Menthol Paraben Free (NDC 79903-030). 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, uses, - warnings, otc - when using, otc - do not use, stop and ask a doctor, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Uses
For the temporary relief of pain
- Warnings
For external use only.
Otc - When Using
avoid contact with the eyes
Do not use more than one patch on your body at a time
Otc - Do Not Use
More than one patch on your body at a time.
On cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor
If you are allergic to any active or inactive ingredients
If pouch is damaged or opened
Stop And Ask A Doctor
■ skin irritation develops
■ condition worsens
■ symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breastfeeding
Ask a health professional before use
Keep Out Of Reach Of Children And Pets
If swallowed, get medical help or contact a Poison Control Center ( 1800-222-1222) right away
Directions
■ Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use.
■ Children under 2 years of age: Do not use, ask a doctor
Other Safety Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Questions or comments? Call toll-free 1-888-287-1915
Inactive Ingredient
carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid,
titanium dioxide, water
* Please review the disclaimer below.
