Active Ingredient
Benzyl alcohol 10%
Lidocaine HCl 4%
Healthwise Lidocaine Plus Cream
FDA Label NDC 71101-037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Lidocaine Plus Cream (NDC 71101-037). 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, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Use
temporarily pain relief
Warnings
For external use only.
Do Not Use
- on wounds or damaged skin
- in large quantities
- with a heating pad
- if you are allergic to any ingredients of this product
When Using This Product
- use only as directed.
- avoid contact with eyes, mucous membranes or rashes
- do not bandage tightly
Stop Use And Ask A Doctor If
- skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days within a few days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.
Directions
adults and children over 12 years:
- clean and dry affected area
- apply a thin layer to affected area not more than 3 to 4 times daily
children 12 years or younger: ask a doctor
Inactive Ingredients
Aloe Vera Leaf, Aminomethyl propanol, butylene glycol, Carbomer Interpolymer Type A (allyl sucrose crosslinked), ceteth-10 phosphate, cetostearyl alcohol, dihexadecyl phosphate, dimethicone, glyceryl 1-stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 mPa.S at 1.5%), maltodextrin, polysorbate 80, SD alcohol, steareth-21, water
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
- Store with lid closed tightly
* Please review the disclaimer below.
