FDA Label for Asperflex 24hrs
View Indications, Usage & Precautions
Asperflex 24hrs Product Label
The following document was submitted to the FDA by the labeler of this product Akron Pharma 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% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic
Purpose
Temporarily relieves minor pain.
Dosage And Administration
Directions Adults and children over 12 years:
- clean and dry affected area
- carefully remove backing from patch starting at corner
- apply sticky side of patch to affected area
- use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age: consult a physician.
Warnings
For external use only.
Idications And Usage
Uses: Temporaily relieves minor pains.
Otc - When Using
When using this product
- use only as directed
- read and follow all directions and warnings on this carton
- do not allow contact with the eyes
- do not use at the same time as other topical analgesics
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not microwave
- dispose of used patch in 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.
Do Not Use
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or 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.
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 800-222-1222
Other Safety Information
Other Safety Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Inactive Ingredient
Inactive Ingredients
Alicyclic Hydrocarbon Resin, Mineral Oil, Polyester film, Silicone –coated polyester film and styrene isoprene styrene block copolymer
NDC: 71399-3884-6
Package size: 6 Patches
Questions?
Please Call 1(877) 225-6999
Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
Manufactured in U.S.A
Re-Lieved Lidocaine 4% Patch
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