FDA Label for Elite Pain Relief

View Indications, Usage & Precautions

Elite Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Meds Direct Rx, 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 Ingredients:



Allantoin  2.00%

Lidocaine  4.00%

Petrolatum  30.00%


Otc - Purpose



Skin Protectant

Topical Anesthetic

SkinProtectant


Uses:



Temporarily protects minor cuts, scrapes and burns

Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations


Warnings:



•For external use only.

•Avoid contact with eyes.

•Stop use and ask a doctor if condition worsens, or symptoms last more than 7 days, or clear up and occur again within a few days.

•Do not use on deep or puncture wounds, animal bites, or serious burns.

•If pregnant or breast feeding, contact physician prior to use.

• Do not use in large quantities, particularly over raw surfaces or blistered areas.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN


Directions:



•Clean and dry affected area

•Remove mesh from backing and apply to affected area

•Use only one mesh at a time, and maximum of 4 mesh/day

• Leave mesh on affected area for up to 8 hours

•Do not use mesh for longer than 5 consecutive days

•Children under 12 should consult physician prior to use


Inactive Ingredients:



Vitamin E, Onion Extract, Dihydroxyaluminum Aminoacetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Polyacrylate, D-Sorbitol, Tartaric Acid, Urea, Sodium Carboxymethylcellulose


Other



Store below 25° degrees. Avoid direct sunlight.

Manufactured For:

Meds Direct Rx, Inc

882 Third Avenue 1Oth Floor Suite 1000

Brooklyn, NY 11232

Questions or Comments call 855-480-MEDS

Made in China


Package Labeling




* Please review the disclaimer below.