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NDC 50488-1025-01 Capsaicin 0.025 g/100g Details
Capsaicin 0.025 g/100g
Capsaicin is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is CAPSAICIN.
MedlinePlus Drug Summary
Topical capsaicin is used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. 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: 50488-1025-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Capsaicin Topical
Product Information
| NDC | 50488-1025 |
|---|---|
| Product ID | 50488-1025_e1749c42-dfe9-4ef0-92e8-a6b41a056fe7 |
| Associated GPIs | 90850025003710 |
| GCN Sequence Number | 006017 |
| GCN Sequence Number Description | capsaicin CREAM (G) 0.025 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 33560 |
| 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 | CREAM |
| 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 50488-1025-01 (50488102501)
| NDC Package Code | 50488-1025-1 |
|---|---|
| Billing NDC | 50488102501 |
| Package | 1 TUBE in 1 CARTON (50488-1025-1) / 120 g in 1 TUBE |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 433da27d-04fb-481a-bbb0-874bb72c806a Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
For external use only
Read all warnings and directions before use. Test first on small area of skin.
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 a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily.
Children under 18 years: Ask a doctor
Inactive ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine
Capsaicin 0.025% cream
NDC 50488-1025-1
120 grams
Capsaicin 0.025% cream
NDC 50488-1025-5
50 grams
Capsaicin 0.025% cream
NDC 50488-1025-2
25 grams
Alexso, Inc
INGREDIENTS AND APPEARANCE
| CAPSAICIN
capsaicin cream |
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| Labeler - Alexso, Inc (963338061) |