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NDC 50488-2025-01 Capsaicin 0.025 g/100g Details
Capsaicin 0.025 g/100g
Capsaicin is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is CAPSAICIN.
MedlinePlus Drug Summary
Nonprescription (over-the-counter) capsaicin patches (Aspercreme Warming, Salonpas Pain Relieving Hot, others) are used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Prescription capsaicin patches (Qutenza) are used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Prescription capsaicin patches (Qutenza) are also used to relieve the pain of diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes). Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.
Related Packages: 50488-2025-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Capsaicin Transdermal Patch
Product Information
| NDC | 50488-2025 |
|---|---|
| Product ID | 50488-2025_ab722340-47c2-6d64-e053-2995a90a14f7 |
| Associated GPIs | 90850025005920 |
| GCN Sequence Number | 022813 |
| GCN Sequence Number Description | capsaicin ADH. PATCH 0.025 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 33562 |
| HICL Sequence Number | 002577 |
| HICL Sequence Number Description | CAPSAICIN |
| Brand/Generic | Generic |
| Proprietary Name | Capsaicin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Capsaicin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH |
| Route | TOPICAL |
| Active Ingredient Strength | 0.025 |
| Active Ingredient Units | g/100g |
| Substance Name | CAPSAICIN |
| Labeler Name | Alexso, Inc |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 50488-2025-01 (50488202501)
| NDC Package Code | 50488-2025-1 |
|---|---|
| Billing NDC | 50488202501 |
| Package | 2 POUCH in 1 BOX (50488-2025-1) / 5 PATCH in 1 POUCH / 100 g in 1 PATCH |
| Marketing Start Date | 2020-01-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 030d67b2-d798-4134-bc96-69536ad46f2d Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
For external use only. Use only as directed or as directed by a health care professional
Read all warnings and directions before use.
Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.
Do not use
• On wounds, cuts, damaged or infected skin
• On eyes, mouth, genitals, or any other mucous membranes
Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.
When using this product
• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
• Avoid contact with the eyes, lips, nose and mucous membranes
• Do not tightly wrap or bandage the treated area
• Do not apply heat to the treated area immediately before or after use
Directions
Adults and children 18 years of age and older:
Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 18 years: Ask a physician
Inactive ingredients
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| CAPSAICIN
capsaicin patch |
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| Labeler - Alexso, Inc (963338061) |