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Elite PAIN RELIEF

Medically reviewed on November 20, 2017.

Dosage form: patch
Ingredients: ALLANTOIN 2g in 100g, LIDOCAINE 4g in 100g, PETROLATUM 30g in 100g
Labeler: Meds Direct Rx, Inc.
NDC Code: 69418-004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Elite Pain Relief Patch

ACTIVE INGREDIENTS:

Allantoin  2.00%

Lidocaine  4.00%

Petrolatum  30.00%

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.

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

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

ELITE PAIN RELIEF 
allantoin, lidocaine, petrolatum patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69418-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN2 g  in 100 g
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ONION 
.ALPHA.-TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:69418-004-1515 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/05/2015
Labeler - Meds Direct Rx, Inc. (064053428)
Establishment
NameAddressID/FEIOperations
Meds Direct Rx, Inc.064053428relabel(69418-004), repack(69418-004)
Establishment
NameAddressID/FEIOperations
Foshan Aqua Gel Biotech Co. Ltd529128763manufacture(69418-004)

 
Meds Direct Rx, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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