Active Ingredient(S)
Lidocaine 4 % +Menthol 1% w/w.
Rapid Relief Patch
FDA Label NDC 83569-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rapid Aid Viet Nam Company Limited for the product Rapid Relief (NDC 83569-016). 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(s), purpose, use, warnings, do not use, when using this product:, stop use and ask a doctor if:, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lidocaine: Topical anesthetic / Menthol: Topical analgesic
Use
For the temporary relief of minor pain.
Warnings
For external use only.
Do Not Use
More than 1 patch at a time
On wounds or damaged skin
With a heating pad such as electric heating pad,as this may result in excessive skin irritation or skin burn
If you are allergic to any ingredients of this product
In large quantities, particularly over raw surfaces or blistered areas
When Using This Product:
Use only as directed
Do not bandage tightly
Avoid contact with eyes, mucous membranes or rashes
If contact occurs, rinse thoroughly with water
Stop Use And Ask A Doctor If:
Localized 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
If Pregnant Or Breastfeeding
If pregnant or breastfeeding, ask a health professional before use.
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.
Directions
Adults and children 12 years of age and older:
Clean and dry affected area
Remove film from patch and apply to the skin
Apply 1 patch at a time to the affected area, not more than 3 times daily.
Remove patch from the skin.
Do not leave on skin for more than a total of 8 hours per day
Children under 12 years of age:
Do not use, consult a physician.
Supervise children when they use this product
Storage And Handling
Store between 15-30℃(59-86℉) keep away from children
Inactive Ingredients
Acryloyldime/ Sodium Acryloyldimethyltaurate copolymer, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetic acid,, Glycerin, Laurocapram，Polyacrylic acid, Propylene glycol, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water
Image
Image (83569 016 01)
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