FDA.reportPublic FDA data

FAST RELIEF REUMACETIN

Manufacturer
Interfarma Corp
Effective date
2015-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:31

Label at a glance#

ProductFAST RELIEF REUMACETIN
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Dosage and administration

Apply to the affected area. Gently massage into the skin for a few seconds. Adults and children over 12 years of age: apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age need to consult a physician.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:                             Purpose:

Menthol 2.5%...................................External Analgesic

Methyl Salicylate 15%......................External Analgesic

Uses

OTC - PURPOSE SECTION

Temporarily relieves 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 this product if safety seal is broken. Store in room temperature.
  • Do not use on wounds or damaged skin. Do not apply in large quantities, particularly on raw and irritated or blistered areas.
  • When using this product, avoid contact with eyes or mucus membranes. Use only as directed. Do not bandage tightly.
  • Stop and ask doctor if condition worsen, if symptoms persist within 7 days or clear up and occur again within a few days. Stop use if excessive skin irritation occurs.
  • If pregnant or breast feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning.

DOSAGE & ADMINISTRATION SECTION

Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or mucous membranes. If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

Directions

INDICATIONS & USAGE SECTION

Apply to the affected area. Gently massage into the skin for a few seconds. Adults and children over 12 years of age: apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age need to consult a physician.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Acrymalide, Amino Acids, Comfrey Leaf, Cetyl Alcohol, Diazolidinyl Urea, Dimethicone, Glucosamine, Methyl Paraben, MSM (Methylsulfonylmethane), Mineral Oil, Panthenol, Propylene Glycol, Propylparaben, Sodium Pyrrolidone Carboxylate, Stearic Acid, Stearyl Alcohol, Trolamine, Water.

Manufactured for:

SPL UNCLASSIFIED SECTION

Interfarma Corp.

Miami, FL 33186.

FAST RELIEF REUMACETIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For Temporarily Relieves minor aches and pains soreness, and stiffness associated with simple backaches strains, arthritis and rheumatism.

Net Wt 8 oz (226g)

Made in USA

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1673877menthol 2.5 % / methyl salicylate 15 % Topical CreamPSN1
1744388Reumacetin 2.5 % / 15 % Topical CreamPSN1
1744388menthol 25 MG/ML / methyl salicylate 150 MG/ML Topical Cream [Reumacetin]SBD1
1673877menthol 25 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1
1673877menthol 2.5 % / methyl salicylate 15 % Topical CreamSY1
1744388Reumacetin (menthol 2.5 % / methyl salicylate 15 % ) Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69706-0204-92020-01-31C16284748780-19d75b9d0-fc2b-f424-e053-dadaa90a57ceFAST RELIEF REUMACETIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69706-0204-9FAST RELIEF REUMACETIN226 g in 1 JARCREAM2261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69706-0204FAST RELIEF REUMACETIN (MENTHOL, METHYL SALICYLATE) CREAM [INTERFARMA CORP]1Legacy NDC, 1 package rows20160324_658689e9-d576-4bc2-bd03-db8dc9f2b0e3.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69706-020469706-0204-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
ACRYLAMIDE20R035KLCIIACT
AMINO ACIDS, WHEAT0370GZL32FIACT
CETYL ALCOHOL936JST6JCNIACT
COMFREY LEAFDG4F8T839XIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLUCOSAMINEN08U5BOQ1KIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PANTHENOLWV9CM0O67ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
cf00f47d-d986-450a-a43c-f2f1871c395a658689e9-d576-4bc2-bd03-db8dc9f2b0e32015-10-01WarningsExact identifier
spl id: cf00f47d-d986-450a-a43c-f2f1871c395a
spl set id: 658689e9-d576-4bc2-bd03-db8dc9f2b0e3

Reported adverse events (FAERS/openFDA)#

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