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NDC 00536-1118-25 Rugby Arthritis Pain Relieving 0.75 mg/g Details
Rugby Arthritis Pain Relieving 0.75 mg/g
Rugby Arthritis Pain Relieving is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. 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: 00536-1118-25Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Capsaicin Topical
Product Information
| NDC | 00536-1118 |
|---|---|
| Product ID | 0536-1118_c221c55e-8bb6-41bf-b31e-a6bb7527811b |
| Associated GPIs | 90850025003730 |
| GCN Sequence Number | 012072 |
| GCN Sequence Number Description | capsaicin CREAM (G) 0.075 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 33561 |
| HICL Sequence Number | 002577 |
| HICL Sequence Number Description | CAPSAICIN |
| Brand/Generic | Generic |
| Proprietary Name | Rugby Arthritis Pain Relieving |
| Proprietary Name Suffix | Topical Analgesic |
| Non-Proprietary Name | Capsaicin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 0.75 |
| Active Ingredient Units | mg/g |
| Substance Name | CAPSAICIN |
| Labeler Name | Rugby Laboratories |
| 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 00536-1118-25 (00536111825)
| NDC Package Code | 0536-1118-25 |
|---|---|
| Billing NDC | 00536111825 |
| Package | 1 TUBE in 1 CARTON (0536-1118-25) / 57 g in 1 TUBE |
| Marketing Start Date | 2017-05-24 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.0818 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | ARTHRITIS PAIN RLF 0.075% CRM |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 8f1bc075-97ac-4154-8768-0d878104c3ba Details
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 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
Stop and ask a doctor if
- ♦
- condition worsens or does not improve after regular use
- ♦
- severe burning persists or blistering occurs
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 - 57 g Tube Carton
INGREDIENTS AND APPEARANCE
| RUGBY ARTHRITIS PAIN RELIEVING
TOPICAL ANALGESIC
capsaicin cream |
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| Labeler - Rugby Laboratories (079246066) |
| Registrant - Garcoa, Inc (036464697) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Garcoa, Inc | 036464697 | MANUFACTURE(0536-1118) | |
Revised: 1/2022
Document Id: c221c55e-8bb6-41bf-b31e-a6bb7527811b
Set id: 8f1bc075-97ac-4154-8768-0d878104c3ba
Version: 2
Effective Time: 20220112