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NDC 63187-0660-60 Rugby Capsaicin 0.25 mg/g Details
Rugby Capsaicin 0.25 mg/g
Rugby Capsaicin is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0660-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Topical
Product Information
| NDC | 63187-0660 |
|---|---|
| Product ID | 63187-660_f63da686-124f-424d-a2af-8a88b36f7523 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Rugby Capsaicin |
| Proprietary Name Suffix | External Analgesic |
| Non-Proprietary Name | Capsaicin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/g |
| Substance Name | CAPSAICIN |
| Labeler Name | Proficient Rx LP |
| 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 63187-0660-60 (63187066060)
| NDC Package Code | 63187-660-60 |
|---|---|
| Billing NDC | 63187066060 |
| Package | 1 TUBE in 1 CARTON (63187-660-60) / 60 g in 1 TUBE |
| Marketing Start Date | 2018-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7c733a30-5002-49e7-a6bd-7737a1d2461e Details
Uses
Warnings
For external use only
Read all warnings and directions before use. Test first on small area of skin.
Do not use
- •
- on wounds or damaged skin
- •
- if you are allergic to capsicum or chili peppers
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
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
INGREDIENTS AND APPEARANCE
| RUGBY CAPSAICIN
EXTERNAL ANALGESIC
capsaicin cream |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | RELABEL(63187-660) | |
Revised: 1/2021
Document Id: f63da686-124f-424d-a2af-8a88b36f7523
Set id: 7c733a30-5002-49e7-a6bd-7737a1d2461e
Version: 3
Effective Time: 20210101