Indications and uses
temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis strains sprains
Rugby ® Capsaicin Cream External Analgesic
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2025-02-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:56:41
Label at a glance#
ProductCapsaicin External Analgesic
Active ingredientCAPSAICIN
Label structure11 sections
Dosage and administration
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
Storage and handling
store at room temperature 15° - 30°C (59° - 86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Capsaicin 0.025%
Purpose
External analgesic
Uses
temporarily relieves minor aches and pains of muscles and joints due to:
- simple backache
- arthritis
- strains
- sprains
Warnings
OTC - DO NOT USE SECTION
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
Stop use and ask a doctor if
- condition worsens or does not improve after regular use
- severe burning persists or blistering occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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
Other information
store at room temperature 15° - 30°C (59° - 86°F)
Inactive ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water
Questions or comments?
Call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday
SPL UNCLASSIFIED SECTION
Mfd for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-3430-2 | 2025-03-04 | C162847 | 48780-1 | 2cef2736-8896-d83d-e063-dadaa90ab31f | Rugby ® Capsaicin Cream External Analgesic |
| 68071-3430-2 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8896-d83d-e063-dadaa90ab31f | Rugby ® Capsaicin Cream External Analgesic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3430-2 | CapsaicinExternal Analgesic | 60 g in 1 TUBE | CREAM | 60 | 2 | |
| 68071-3430-2 | CapsaicinExternal Analgesic | 1 in 1 CARTON | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3430 | CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20250306_fd90a67d-d60d-a849-e053-6394a90a2cc8.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-2525-25 | GM - Gram | 0536-2525 | 68eb3219-f221-4b69-88f5-6cbd7f09bbc1 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Capsaicin External Analgesic
- Capsaicin
- CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- CETYL ACETATE
- METHYLPARABEN
- PPG-20 METHYL GLUCOSE ETHER DISTEARATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- STEARETH-100
- STEARIC ACID
- STEARYL ALCOHOL
- TROLAMINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-3430 | 68071-3430-2 |
| 0536-2525 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Capsaicin External Analgesic | CAPSAICIN | NuCare Pharmaceuticals,Inc. | fd90a67d-d60d-a849-e053-6394a90a2cc8 | 2025-02-04 | Warnings | 68071-3430-2 68071-3430 68071343002 2d587184-fc1f-2fda-e063-6394a90a32fa fd90a67d-d60d-a849-e053-6394a90a2cc8 |
| Capsaicin | CAPSAICIN | Rugby Laboratories | c5915c84-84a2-46f6-9f97-0d9873e9944a | 2024-02-12 | Warnings | 0536-2525 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.