Lidoguard Patch
FDA Label NDC 85231-100
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Violacare, Inc. for the product Lidoguard (NDC 85231-100). 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 drug facts, active ingredients, purpose, uses:, warnings:, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine 4%
Purpose
External Anesthetic
Uses:
Temporarily relieves minor pain
Warnings:
For external use only
Otc - Do Not Use
Do not use
- More than 1 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
- At the same time as other topical analgesics
Otc - When Using
When using the product
- Use only as directed
- Read and follow all directions and warnings on this label
- Rare cases of serious burns have been reported with products of this type
- Do not apply to wounds or damaged, broken, or irritated skin
- Do not allow contact with the eyes and mucous membranes
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use
- Do not use at the same time as other topical analgesics
- Dispose of used patch in a manner that always keeps the 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
- A transient burning sensation may occur upon application but generally disappears in several days
- If a severe burning sensation occurs, discontinue use immediately
- Discontinue use at least 1 hour before a bath or shower
- Do not use immediately use after a bath or shower
Otc - Stop Use
Stop use and ask doctor if
- Your condition worsens
- Redness is present
- Irritation develops
- Symptoms persist for more than 7 days or a 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
Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adult and children over 12 years:
- Clean and dry affected area
- Remove backing from patch by firmly grasping both ends and gently pulling until back separates in the middle
- Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
- Use 1 patch for up to 12 hours
Children 12 years or younger:Ask a doctor
Other Information:
Store at room temperature 20° - 25°C (68°-77°F)
Inactive Ingredient
Inactive Ingredients: Alpha Tocopherol Acetate, Aluminum Glycinate, Aluminum Hydroxide, Aluminum Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Propylene Glycol, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartric Acid & Titanium Dioxide
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