ELITE PAIN RELIEF- allantoin, lidocaine, petrolatum patch

Elite PAIN RELIEF by

Drug Labeling and Warnings

Elite PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Meds Direct Rx, Inc., Foshan Aqua Gel Biotech Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Allantoin  2.00%

Lidocaine  4.00%

Petrolatum  30.00%

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.

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

SPL UNCLASSIFIED SECTION

Store below 25° degrees. Avoid direct sunlight.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ELITE PAIN RELIEF 
allantoin, lidocaine, petrolatum patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69418-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	2 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ONION (UNII: 492225Q21H)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69418-004-15	15 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/05/2015

Labeler - Meds Direct Rx, Inc. (064053428)

Establishment
Name	Address	ID/FEI	Business Operations
Meds Direct Rx, Inc.		064053428	relabel(69418-004) , repack(69418-004)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co. Ltd		529128763	manufacture(69418-004)