Otc - Active Ingredient
Lidocaine 4.0%
Menthol 1.0%
Equate Lidocaine Cool And Heat Patch
FDA Label NDC 79903-038
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 Cool And Heat (NDC 79903-038). 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
Topical Anesthetic
Topical Anesthetic
Uses
Temporarily relieves minor pain
- Warnings
For external use only.
Otc - When Using
Use only as directed
Read and follow all directions and warnings on this carton
Do not allow contact with the eyes
Do not use at the same time as other topical analgesics
Do not bandage tightly or apply local heat (such as heating pads) to the area of use
Do not microwave
Dispose of the used patch in a 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.
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
Condition worsens
Redness is present
Irritation develops
Symptoms persist for more than 7 days or clear up and occur again within a few days
You experience signs of skin injury, such as pain, swelling or blistering where the product was applied
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 12 years of age and over: Clean and the dry affected area. Carefully remove backing from the patch starting at a corner. Apply the sticky side of patch to the affected area. Use one patch for up to 12 hours. Discard patch after a single use. Children under 12 years old of age: consult a physician.
Other Safety Information
Store in a clean, dry place outside of direct sunlight. Protect for excessive moisture.
Inactive Ingredient
Aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water
* Please review the disclaimer below.
