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Ultimate Topical Pain Relief Patch

Medically reviewed on October 16, 2017

Dosage form: patch
Ingredients: MENTHOL, UNSPECIFIED FORM 5g in 100g, CAPSAICIN 0.0375g in 100g
Labeler: G&N Enterprise,LLC
NDC Code: 69731-010

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.

Ultimate Topical Pain Relief Patch

Active Ingredients

Menthol 5.00%

Capsaicin 0.0375%

Purpose:

External Analgesic/Counterirritant

External Analgesic/Counterirritant

Uses:

Temporarily relieves minor aches and muscle pain associated with simple back ache, arthritis, strains and sprains. Use only as directed.

Warnings
  • For external useonly.
  • Avoid contact with eyes and mucous membranes.
  • Do not use on wounds or damaged skin.
  • Do not cover with bandage.
  • Do not use if you are allergic to Menthol.
  • Consult physician for use on children under 12.

Stop use and ask a doctor if

conditions worsen, if symptoms persist for more than 7 days or clear up and occur again with a few days, or if a rash,

itching or excessive skin irritation occurs.

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 12 and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years: Consult physician before use.

Other Information

Store below 25°C (77°F). Avoid direct sunilght.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium ,Glycerin, Iodopropynyl Butylcarbamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.

Questions or Comments?

Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

Dosage and Administration

Ultimate Topical Pain Relief Patch contains 0.0375% capsaicin and 5.00% menthol

Ultimate Topical Pain Relief Patch

ULTIMATE TOPICAL PAIN RELIEF PATCH 
capsaicin and menthol, unspecified form patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69731-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
GLYCERIN 
IODOPROPYNYL BUTYLCARBAMATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
WATER 
ALOE VERA LEAF 
SODIUM POLYACRYLATE (2500000 MW) 
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69731-010-051 POUCH in 1 CARTON
15 PATCH in 1 POUCH
19 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2016
Labeler - G&N Enterprise,LLC (079758164)
Establishment
NameAddressID/FEIOperations
G & N Enterprise, LLC079758164relabel(69731-010), repack(69731-010)

 
G&N Enterprise,LLC

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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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