FDA.reportPublic FDA data

Rugby ® Capsaicin Cream External Analgesic

Manufacturer
Rugby Laboratories | Garcoa, Inc. | SV Labs Toronto Corporation
Effective date
2024-02-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:26:36

Label at a glance#

ProductCapsaicin
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 - 60 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0536-2525-25

Rugby®

SATISFACTION GUARANTEED
Rugby
OR YOUR MONEY BACK

Capsaicin Cream, 0.025%

External Analgesic
Penetrating Pain Relief

Net Wt 2.1 oz (60 g)

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198555capsaicin 0.025 % Topical CreamPSN8
198555capsaicin 0.25 MG/ML Topical CreamSCD8
198555capsaicin 0.025 % Topical CreamSY8

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
0536-2525-252022-02-01C16284748780-1d6a99b39-e84d-a426-e053-dadaa90af4c2Rugby ® Capsaicin Cream External Analgesic
0536-2525-252022-02-01C16284748780-1d6a99b39-e84d-a426-e053-dadaa90af4c2Rugby ® Capsaicin Cream External Analgesic
0536-2525-252022-01-28C16284748780-1d6a99b39-e84d-a426-e053-dadaa90af4c2Rugby ® Capsaicin Cream External Analgesic
0536-2525-252022-01-28C16284748780-1d6a99b39-e84d-a426-e053-dadaa90af4c2Rugby ® Capsaicin Cream External Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-2525-25Capsaicin1 in 1 CARTONCREAM18
0536-2525-25Capsaicin60 g in 1 TUBECREAM608

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CapsaicinACTIVE INGREDIENTS07O44R1ZM2
CapsaicinACTIVE MOIETYS07O44R1ZM2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L2
Cetyl AcetateINACTIVE INGREDIENT4Q43814HXS2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
PPG-20 Methyl Glucose Ether DistearateINACTIVE INGREDIENT0057334FAB2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V32
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
Steareth-100INACTIVE INGREDIENT4OH5W9UM872
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1Y2
TrolamineINACTIVE INGREDIENT9O3K93S3TK2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-25250536-2525-25

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CapsaicinS07O44R1ZMACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
Cetyl Acetate4Q43814HXSIACT
MethylparabenA2I8C7HI9TIACT
PPG-20 Methyl Glucose Ether Distearate0057334FABIACT
Propylene Glycol6DC9Q167V3IACT
PropylparabenZ8IX2SC1OHIACT
Steareth-1004OH5W9UM87IACT
Stearic Acid4ELV7Z65APIACT
Stearyl Alcohol2KR89I4H1YIACT
Trolamine9O3K93S3TKIACT
Water059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-02-12monthly-update2026-06-03 17:40:39

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TrolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Stearyl AlcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PPG-20 Methyl Glucose Ether DistearatePPG-20 METHYL GLUCOSE ETHER DISTEARATE0057334FABGEL / TOPICAL48 mgExact identifier — unii+route
2 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Stearyl AlcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Steareth-100STEARETH-1004OH5W9UM87CREAM / TOPICAL50 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Steareth-100STEARETH-1004OH5W9UM87CREAM / TOPICAL50 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PPG-20 Methyl Glucose Ether DistearatePPG-20 METHYL GLUCOSE ETHER DISTEARATE0057334FABGEL / TOPICAL48 mgExact identifier — unii+route
2 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CapsaicinCAPSAICINRugby Laboratoriesc5915c84-84a2-46f6-9f97-0d9873e9944a2024-02-12WarningsExact identifier
ndc (package): 0536-2525-25
ndc (product): 0536-2525
ndc11 (package): 00536252525
spl id: a8b02e2a-9971-482b-97f4-82f344bd79db
spl set id: c5915c84-84a2-46f6-9f97-0d9873e9944a

Reported adverse events (FAERS/openFDA)#

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