Capsaicin 0.025% by Advanced Rx of Tennessee, LLC CAPSAICIN 0.025% patch

Capsaicin 0.025% by

Drug Labeling and Warnings

Capsaicin 0.025% by is a Otc medication manufactured, distributed, or labeled by Advanced Rx of Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Capsaicin 0.025% w/w

Purpose

External analgesic

Uses

For temporary relief of minor aches & pains of muscles & joints associated with:

• simple backache
• arthritis
• stratins
• bruises
• sprains

Warnings

For external use only

Do not use

• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product

When using this product

• Use only as directed
• Avoid contact with the eyes, mucous membranes or rashes
• Do not bandage tightly

Stop use and ask a doctor if

• Rash, itching or excessive skin irratation develops
• Condition worsen
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

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

Adult and Children 12 years of age and over:

• Clean and dry affected area
• Remove film from patch and apply to the skin
• Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
• Remove patch from the skin after at most 8-hour application

Children under 12 years of age:Consult a doctor

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Inactive Ingredients

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Isopropyl Myristate, Polysorbate 80, PVP, Hydroxyacetophenone, Dihydroxyaluminum Aminoacetate, L-Tartaric Acid, Titanium Dioxide, Carboxymethylcellulose Sodium, Kaolin, Edetate Disodium.

Questions or Comments

Call toll free (307) 410-3813 or info@marcellahealth.com

Drug Facts

INGREDIENTS AND APPEARANCE

CAPSAICIN 0.025% 
capsaicin 0.025% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80425-0541(NDC:85096-401)
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	2.5 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POVIDONE K90 (UNII: RDH86HJV5Z)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80425-0541-1	30 in 1 BOX	08/08/2025
1		10 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 Drug	M017	08/08/2025

Labeler - Advanced Rx of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Business Operations
Advanced Rx of Tennessee, LLC		117023142	repack(80425-0541)