Rugby Capsaicin Cream

Manufacturer
Rugby Laboratories | Trifecta Pharmaceuticals USA LLC
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:19:26

Label at a glance#

ProductRugby Capsaicin Cream
Active ingredientCAPSAICIN
Label structure12 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: Arthritis Simple Backache Strains Sprains Bruises

Dosage and administration

Adults and Children over 18 years: Apply to affected area Massage into the painful area until thoroughly absorbed Repeat as necessary but not more than 3 to 4 times daily WASH HANDS WITH SOAP AND WATER AFTER APPLYING Children 18 years and younger: Ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Warnings

WARNINGS SECTION

For external use only: TEST FIRST ON SMALL AREA OF SKIN.

When using this product:

  • Use only as directed
  • Do not apply to wounds, damaged, broken or irritated sin
  • Do not use if you are allergic to capssicum or chili peppers
  • Avoid contact with the eyes or mucous membranes
  • A slight burning sensation may occur upon application, but generally disappears after several days of use
  • If severe burning occurs, discontinue use
  • Do not expose the treated area to heat or direct sunlight
  • Do not bandage
  • Do not use with heating pad

Stop Use and Ask Doctor

OTC - STOP USE SECTION

Stop Use and Ask Doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present
  • irritation develops

Keep Out of the Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a doctor before use

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 18 years:

  • Apply to affected area
  • Massage into the painful area until thoroughly absorbed
  • Repeat as necessary but not more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Children 18 years and younger:

Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, stearic acid.

Questions

OTC - QUESTIONS SECTION

Call 1-800-645-2158

Distributed By:

RUGBY®LABORATORIES

Livonia, MI 48152

www.rugbylaboratories.com

rev. 09/21 R-167 Re-order No. 370818

Other Information

STORAGE AND HANDLING SECTION

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5882244 CAH RGB Capsaicin Cream 42.5g CDER5882244 CAH RGB Capsaicin Cream 42.5g CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
646333capsaicin 0.1 % Topical CreamPSN5
646333capsaicin 1 MG/ML Topical CreamSCD5
646333capsaicin 0.1 % Topical CreamSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130305361264567GTIN-13: 0305361264567
EAN-13: 0305361264567
GTIN-12: 305361264567
UPC-A: 305361264567
GTIN storage (14 digits): 00305361264567
5882244 CAH RGB Capsaicin Cream 42.5g CDER.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1264-56Rugby Capsaicin Cream42.5 g in 1 TUBECREAM42.55
0536-1264-56Rugby Capsaicin Cream1 in 1 BOXCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1264-56GM - Gram0536-1264f71605dd-730f-4fa3-9f4b-a4152a18787a12020-08-06

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
0536-12640536-1264-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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
Rugby Capsaicin CreamCAPSAICINRugby Laboratories9eca34f1-e91a-3ac1-e053-2a95a90a9bd92025-12-02WarningsExact identifier
ndc (package): 0536-1264-56
ndc (product): 0536-1264
ndc11 (package): 00536126456
spl id: 44fdaeff-78d9-d05c-e063-6294a90ac1c0
spl set id: 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9

Reported adverse events (FAERS/openFDA)#

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