FDA.reportPublic FDA data

PAIN THERAPY

Manufacturer
Renu Laboratories, Inc.
Effective date
2021-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:23

Label at a glance#

ProductPAIN THERAPY
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure14 sections

Indications and uses

Temporarily relieves minor aches and pains of muscle and joints due to: arthritis, simple backache, sprains, strains and bruises

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

Methyl Salicylate 10%

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

Topical Analgesic

USES

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscle and joints due to: arthritis, simple backache, sprains, strains and bruises

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Do not apply to wounds or damaged skin
  • Do not bandage tightly
  • Do not use in or near eyes; if product gets into eyes rinse thoroughly with water
  • Do not use with an electric heating pad

Stop use and ask doctor if

OTC - STOP USE SECTION

  • Conditions worsen
  • Symptoms last for more than 7 days or clear up and occur again within a few days
  • A rash or irritation develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.

ARCTIC HEAT

STATEMENT OF IDENTITY SECTION

Dual Active Botanical Warming Formula with Emu Oil

OTC - QUESTIONS SECTION

Manufactured by:

Renu Labs Inc.

Ivyland, PA 18974

www.RenuLabs.com

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and

older: Apply directly to affected area no more than 3 to 4 times daily.

RECENT MAJOR CHANGES SECTION

No major changes to any section.

This is a simple product name change.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RANCHO SAN DIEGO PAIN RELIEF TUBE

rancho PR TUBErancho PR TUBE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2198895menthol 2 % / menthyl salicylate 10 % Topical CreamPSN1
2198895menthol 20 MG/ML / menthyl salicylate 100 MG/ML Topical CreamSCD1
2198895menthol 2 % / menthyl salicylate 10 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-640-042025-01-30C16284748780-12cef2736-67e3-d83d-e063-dadaa90ab31fRSD EMU OIL PAIN THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-640-04PAIN THERAPY112 g in 1 TUBECREAM1121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-640PAIN THERAPY (MENTHOL, METHYL SALICYLATE) CREAM [RENU LABORATORIES, INC.]1Legacy NDC, 1 package rows20210518_c2500db1-eccc-9166-e053-2a95a90a450a.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
76348-64076348-640-04

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
PEG-100 STEARATEYD01N1999RIACT
TABASCO PEPPERJ1M3NA843LIACT
ALLANTOIN344S277G0ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT
LAURETH-7Z95S6G8201IACT
STEARIC ACID4ELV7Z65APIACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)5F4963KLHSIACT
MENTHOLL7T10EIP3AACTIB
EMU OIL344821WD61IACT
EUCALYPTUS OIL2R04ONI662IACT
NIACINAMIDE25X51I8RD4IACT
METHYL SALICYLATELAV5U5022YACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
WATER059QF0KO0RIACT
PEPPERMINT OILAV092KU4JHIACT
C13-14 ISOPARAFFINE4F12ROE70IACT

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
c24fff8a-fb22-6d6b-e053-2995a90a1831c2500db1-eccc-9166-e053-2a95a90a450a2021-05-14WarningsExact identifier
spl id: c24fff8a-fb22-6d6b-e053-2995a90a1831
spl set id: c2500db1-eccc-9166-e053-2a95a90a450a

Reported adverse events (FAERS/openFDA)#

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