FDA Label for Pure Cbd Hydrogel Xl With Lidocaine 4%
View Indications, Usage & Precautions
Pure Cbd Hydrogel Xl With Lidocaine 4% Product Label
The following document was submitted to the FDA by the labeler of this product Ari Brands, Llc. 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%
Purpose
Topical Anesthetic
Uses
Temporarily relieves pain and itching associated with:
• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations
Warnings
For external use only.
Do Not Use
• More than one patch at a time or on irritated or swollen skin
• On wounds, damaged, or infected skin
• On eyes, mouth, genitals or other mucous membranes
• With a heating pad
• If you are allergic to any ingredients of this product
Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.
When Using This Product
• Use only as directed. Read and follow all directions and warnings on the carton and packet insert before use.
• Avoid contact with eyes, mucous membranes, or rashes.
• 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 or anesthetics.
• Dispose of 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.
Stop Use And Consult A Physician:
• If pregnant or breast feeding
• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 12 years of age and older:
Apply 1 patch to the affected area of intact skin up to 12 hours.
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 12 years: Ask a physician
Other Information
Store at room temperature 15°-30°C (59°-86°F)
Avoid storing product in direct sunlight and protect product from excessive moisture.
Inactive Ingredients
CBD (Hemp Extract), Dihydroxyaluminium Aminoacetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitol, Tartaric Acid, Urea and Purified Water.
Principal Display Panel
Pure CBD Hydrogel XL Patch with Lidocaine 4%
NDC 71436-3004-5
5 Patches
Ari Brands, LLC
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