FDA.reportPublic FDA data

ARCTIC HEAT

Manufacturer
Renu Laboratories, LLC
Effective date
2025-08-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:13:36

Label at a glance#

ProductARCTIC HEAT
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure13 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.

ARCTIC HEAT TUBE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ARCTIC HEAT tmARCTIC HEAT tm

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311503menthol 2 % / methyl salicylate 10 % Topical CreamPSN8
311503menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD8
311503menthol 2 % / methyl salicylate 10 % Topical CreamSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-414-012025-09-12C16284748780-12cef2736-b11d-d83d-e063-dadaa90ab31fARCTIC HEAT
76348-414-012025-01-30C16284748780-12cef2736-b11d-d83d-e063-dadaa90ab31fARCTIC HEAT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-414-01ARCTIC HEAT112 g in 1 TUBECREAM1128

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
76348-41476348-414-01

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

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
ARCTIC HEATMENTHOL, METHYL SALICYLATERenu Laboratories, LLC402df5c1-b8cb-17a2-e054-00144ff8d46c2025-08-27WarningsExact identifier
ndc (package): 76348-414-01
ndc (product): 76348-414
ndc11 (package): 76348041401
spl id: 3d5eac90-4d43-e697-e063-6294a90ae0e2
spl set id: 402df5c1-b8cb-17a2-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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