Elite pain relief patch

Active ingredients:

Allantoin 2.00%

Lidocaine 4.00%

Petrolatum 30.00%

Otc - purpose section

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 section

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

Ingredients and appearance - Product information

Elite pain relief patch- Allantoin, lidocaine, petrolatum

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Allantoin ( UNII: 344S277G0Z)( Allantoin - UNII: 344S277G0Z ) 2 gin 100 g
Lidocaine ( UNII: 98PI200987)( Lidocaine - UNII: 98PI200987 ) 4 gin 100 g
Petrolatum ( UNII: 4T6H12BN9U)( Petrolatum - UNII: 4T6H12BN9U ) 30 gin 100 g

Inactive Ingredients

Ingredient Name Code
Onion ( UNII: 492225Q21H)
.alpha.-tocopherol ( UNII: H4N855PNZ1)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part347 USA

Labeler - Meds Direct Rx, Inc.( 064053428)

Establishment

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

Package labeling