TRANS-D- menthol, capsaicin solution
Advance Medical Sales, 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.

----------

Trans-D Patch, 15 count

Drug Facts

Active Ingredients

Menthol 5.00%, Capsaicin 0.0375%

Anatgesic/Counterirritant, External Analgesic

Uses

For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, brulses and strains.

Warnings

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
Do not cover with bandage.
Do not use on wounds or damaged skin.
Do not use in combination with any other external analgesic products.
Avoid Contact with eyes and mucous membranes.
Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.

Keep out of reach of children

Consult physician for children under 12.

Do not use if you are allergic to Menthol.

Stop use and ask a doctor

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

or Rash, itching or excessive skin irritation occurs.

Directions

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

• Clean and dry affected area

• Remove protective film and apply directly to area of pain

• Apply to affected area not more than 3 times daily

• Wash hands with soap after applying patch

• Reseal pouch containing unused patches

Other Ingredients

WATER, GLYCERINE, SODIUM POLYACRYLATE, POLYSORBATE 80, ALOE BARBADESIS LEAF (ALOE VERA
GEL) JUICE, EDTA DISODIUM SALT, DIAZOLIDINYL UREA, METHYLPARABEN, LODOPROYNYL BUTYLCABAMATE, PROPYLPARABEN.

Product Label

Trans-D Patch

TRANS-D
menthol, capsaicin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69717-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.375 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69717-004-15	15 in 1 BOX	03/19/2015	12/31/2016
1		8 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	03/19/2015	12/31/2016

Labeler - Advance Medical Sales, LLC (079763209)

Revised: 1/2017

Document Id: 4662fe6f-2f0c-39ef-e054-00144ff8d46c

Set id: b8d0744b-cc61-46ed-86ee-355207dc37ae

Version: 3

Effective Time: 20170118

Advance Medical Sales, LLC