CAPSIMIDE- capsaicin 0.025% topical patch patch

Capsimide by

Drug Labeling and Warnings

Capsimide by is a Otc medication manufactured, distributed, or labeled by Sola Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Capsaicin 0.025%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain.

Warnings

For external use only

Do not use

• more than one patch on your body at a time
• on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor
• if you are allergic to any active or inactive ingredients
• if pouch is damaged or opened

When using this product

• use only as directed
• read and follow all directions and warnings on this carton
• do not allow contact with the eyes
• do not sue at the same time as other topical analgesics
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not microwave
• dispose of used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

If pregnant or breast-feeding

ask a health professional before use.

Keep our of reach of children

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

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use. Children under 12 years of age: consuly a physician.

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Other Ingredients

Glycerin, Sodium polyacrylate, Dihydroxyaluminum aminoacetate, Edetate disodium, Kaolin, Carboxymethylcellulose sodium, Titanium dioxide, L-Tartaric acid, Polyacrylic acid, Propylene glycol, Polysorbate 80, Isopropyl Myristate, Hydroxyacetophenone, Water, and PVP

Questions or comments?

866-747-7365

PRINCIPAL DISPLAY PANEL

Manufactured for:

SOLA PHARMACEUTICALS LLC

Baton Rouge, LA 70810

www.solameds.us

Made in China

Capsimide Patch

NDC: 70512-016-10

Qty: 10 Patches

(1 per pouch) x 10

INGREDIENTS AND APPEARANCE

CAPSIMIDE 
capsaicin 0.025% topical patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70512-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
KAOLIN (UNII: 24H4NWX5CO)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70512-016-10	10 in 1 BOX	09/07/2022
1		9 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/07/2022

Labeler - Sola Pharmaceuticals (080121345)