FDA Label for Laboflex Lidocaine Pain Relieving Patch
View Indications, Usage & Precautions
Laboflex Lidocaine Pain Relieving Patch Product Label
The following document was submitted to the FDA by the labeler of this product Laboflex, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine 4%
Inactive Ingredients
Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Lidocaine, Urea, Methyl paraben, Partially neutralized Sodium Polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl paraben, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water.
Directions:
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use, consult a physiciacn.
- clean and dry affected area
- remove the film from the patch and apply to the affected area
- Use 1 patch at a time and not more than 3 to 4 times daily.
- Remove patch from the skin after at most 8 hours application
Keep Out Of Reach Of Children
Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Stop Use And Ask A Doctor If
Stop use and ask doctor if:
- Condition worsens
- Symptoms persist for more than 7 days or clear up and occur again within a few days
- Severe burning sensation, redness or irritation developss
- You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
When Using This Product
When using the product:
- use only as directed.
- do not bandage tightly
- Avoid contact with the eyes, mucous membranes or rashes
- do not apply to open wounds or damaged skin
Do Not Use
Do not use:
- On wounds or damaged skin
- With a heantig pad
- If you are allergic to any ingredients of this product
Warning
For external use only
Uses
For the temporary relief of pain
Purpose
Topical anesthetic
Other Information
Other Information:
- Do not use if the pouch is opened or damaged
- Tighlty reseal the pouch containing unused patches
- Store at room temperature
- Do not freeze
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