FDA.reportPublic FDA data

Rugby ® Ice Blue Gel External Analgesic

Manufacturer
Rugby Laboratories | Garcoa, Inc.
Effective date
2024-03-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:17:44

Label at a glance#

ProductRugby Ice Blue External Analgesic
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Dosage and administration

Clean affected area before applying product. adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. children under 2 years of age: do not use, consult a doctor.

Storage and handling

store at room temperature 20 to 25°C (68 to 77°F) Keep lid tightly closed. Do not use, pour, spill or store near heat or open flame.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.0%

Purpose

OTC - PURPOSE SECTION

Pain relieving gel

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • with other topical pain relievers.
  • with heating pads or other heating devices.

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes.
  • do not apply to wounds or damaged skin.
  • do not bandage tightly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • redness or irritation develops.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a health professional before use.

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

  • Clean affected area before applying product.
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 20 to 25°C (68 to 77°F)
  • Keep lid tightly closed.
  • Do not use, pour, spill or store near heat or open flame.

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby® NDC 0536-1061-39

Blue Gel
External Analgesic
Pain Relieving Gel for Minor
Aches and Pains of Muscles
and Joints

COMPARE TO ACTIVE INGREDIENT
IN MINERAL ICE®*

NET WT 8 OZ
(226.8 g)

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label
PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311502menthol 2 % Topical GelPSN5
311502menthol 0.02 MG/MG Topical GelSCD5
311502menthol 2 % Topical GelSY5
311502menthol 2 % topical stickSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1061-392020-03-20C16284748780-19d75b9d1-09ed-f424-e053-dadaa90a57ceRugby ® Ice Blue Gel External Analgesic
0536-1061-392020-01-31C16284748780-19d75b9d1-09ed-f424-e053-dadaa90a57ceRugby ® Ice Blue Gel External Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1061-39Rugby Ice BlueExternal Analgesic226.8 g in 1 JARGEL226.85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1061-39GM - Gram0536-1061e9f23715-1a08-496d-8632-9ca7714b1fc912015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
AmmoniaINACTIVE INGREDIENT5138Q19F1X1
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS3111
Cupric SulfateINACTIVE INGREDIENTLRX7AJ16DT1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD1
Isopropyl AlcoholINACTIVE INGREDIENTND2M4163021
Magnesium Sulfate AnhydrousINACTIVE INGREDIENTML30MJ2U7I1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
ThymolINACTIVE INGREDIENT3J50XA376E1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-10610536-1061-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
Ammonia5138Q19F1XIACT
FD&C Blue No. 1H3R47K3TBDIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
Cupric SulfateLRX7AJ16DTIACT
Isopropyl AlcoholND2M416302IACT
Magnesium Sulfate AnhydrousML30MJ2U7IIACT
Sodium Hydroxide55X04QC32IIACT
Thymol3J50XA376EIACT
Water059QF0KO0RIACT

Source Document#

Source XML

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cupric SulfateCUPRIC SULFATELRX7AJ16DTSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
4 equally ranked IID candidates
Cupric SulfateCUPRIC SULFATELRX7AJ16DTSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
4 equally ranked IID candidates
ThymolTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii+dosage form
8 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ThymolTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
Magnesium Sulfate AnhydrousMAGNESIUM SULFATE ANHYDROUSML30MJ2U7ICAPSULE / ORAL29.8 mgExact identifier — unii candidate
2 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii+route
12 equally ranked IID candidates
ThymolTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
Magnesium Sulfate AnhydrousMAGNESIUM SULFATE ANHYDROUSML30MJ2U7ICAPSULE / ORAL29.8 mgExact identifier — unii candidate
2 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
Cupric SulfateCUPRIC SULFATELRX7AJ16DTSOLUTION / AURICULAR (OTIC)NAExact identifier — unii candidate
4 equally ranked IID candidates
AmmoniaAMMONIA SOLUTION5138Q19F1XGEL / TOPICAL1.2 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ThymolTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
AmmoniaAMMONIA SOLUTION5138Q19F1XGEL / TOPICAL1.2 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii+dosage form
8 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii+route
12 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Cupric SulfateCUPRIC SULFATELRX7AJ16DTSOLUTION / AURICULAR (OTIC)NAExact identifier — unii candidate
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
8 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii+route
12 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
8 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
Rugby Ice Blue External AnalgesicMENTHOL, UNSPECIFIED FORMRugby Laboratories2b65cb6a-4364-4770-b7b9-5c4637edd01a2024-03-14WarningsExact identifier
ndc (package): 0536-1061-39
ndc (product): 0536-1061
ndc11 (package): 00536106139
spl id: 3a605963-eddd-4402-b75c-a308ef688cb0
spl set id: 2b65cb6a-4364-4770-b7b9-5c4637edd01a

Reported adverse events (FAERS/openFDA)#

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