ULTIMATE TOPICAL PAIN RELIEF PATCH- capsaicin and menthol, unspecified form patch
G&N Enterprise,LLC

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.

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Ultimate Topical Pain Relief Patch

Active Ingredients

Menthol 5.00%

Capsaicin 0.0375%

Purpose:

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

Box Image

ULTIMATE TOPICAL PAIN RELIEF PATCH
capsaicin and menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69731-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69731-010-05	1 in 1 CARTON	05/01/2016	11/01/2020
1		5 in 1 POUCH
1		9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2016	11/01/2020

Labeler - G&N Enterprise,LLC (079758164)

Name	Address	ID/FEI	Business Operations
Establishment
G & N Enterprise, LLC		079758164	relabel(69731-010) , repack(69731-010)

Revised: 11/2020

Document Id: b458a822-dc07-3bf2-e053-2a95a90a038c

Set id: 33ec413d-c8c4-336b-e054-00144ff8d46c

Version: 7

Effective Time: 20201117

G&N Enterprise,LLC