Capsimide Patch

Capsimide Patch
SPL v4
SPL
SPL Set ID e81c2de8-6429-d681-e053-2995a90a36a9
Route
TOPICAL
Published
Effective Date 2022-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Propylene Glycol Hydroxyacetophenone Water Dihydroxyaluminum Aminoacetate Edetate Disodium Kaolin Carboxymethylcellulose Sodium Sodium Polyacrylate (8000 Mw) Povidone Titanium Dioxide Tartaric Acid Polyacrylic Acid (8000 Mw) Polysorbate 80 Isopropyl Myristate Glycerin

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-07

Description

Capsaicin 0.025%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.025%

Uses

Temporarily relieves minor pain.

Section 51945-4

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

Warnings

For external use only

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.

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
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

Active Ingredients

Capsaicin 0.025%

Questions Or Comments?

866-747-7365

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.


Structured Label Content

Uses

Temporarily relieves minor pain.

Section 51945-4 (51945-4)

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

Purpose

Topical Analgesic

Warnings

For external use only

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.

Do Not Use (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
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

Active Ingredients

Capsaicin 0.025%

Questions Or Comments? (Questions or comments?)

866-747-7365

When Using This Product (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 (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Our of Reach of Children (Keep our of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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