Rugby ® Capsaicin Cream External Analgesic

Manufacturer
medsource pharmaceuticals | Garcoa, Inc.
Effective date
2018-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:53

Label at a glance#

ProductRugby Capsaicin External Analgesic
Active ingredientCAPSAICIN
Label structure11 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis strains sprains

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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198555capsaicin 0.025 % Topical CreamPSN1
198555capsaicin 0.25 MG/ML Topical CreamSCD1
198555capsaicin 0.025 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-773-012025-01-30C16284748780-12cef2736-6d1d-d83d-e063-dadaa90ab31fRugby ® Capsaicin Cream External Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-773-01Rugby CapsaicinExternal Analgesic60 g in 1 TUBECREAM601
45865-773-01Rugby CapsaicinExternal Analgesic1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-773RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20181221_7d77048b-b0b2-9ef8-e053-2991aa0a6a8f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-2525-25GM - Gram0536-252568eb3219-f221-4b69-88f5-6cbd7f09bbc112012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45865-77345865-773-01
0536-2525

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CapsaicinCAPSAICINRugby Laboratoriesc5915c84-84a2-46f6-9f97-0d9873e9944a2024-02-12WarningsExact identifier
ndc (product): 0536-2525
7d772113-5b4b-3465-e053-2991aa0a16877d77048b-b0b2-9ef8-e053-2991aa0a6a8f2018-12-20WarningsExact identifier
spl id: 7d772113-5b4b-3465-e053-2991aa0a1687
spl set id: 7d77048b-b0b2-9ef8-e053-2991aa0a6a8f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.