FDA.reportPublic FDA data

Theralast Maximum Strength Pain Relief Gel

Manufacturer
SKIN SHERPA NORTH AMERICA LLC
Effective date
2022-03-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:51

Label at a glance#

ProductTheralast Maximum Strength Pain Relief Gel
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

Use only as directed Adults and children over 12 years : apply to affected area not more than 4 times daily. Children under 12 years of age : Consult physician.

Storage and handling

Store in cool dry place

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • strains
  • sprains
  • bruises
  • arthritis

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body
  • with other ointments, creams, sprays or liniments
  • with heating pad

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

sensitive skin or redness over the affected area

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin
  • do not bandage
  • wash hands after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

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 accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use only as directed
  • Adults and children over 12 years: apply to affected area not more than 4 times daily.
  • Children under 12 years of age: Consult physician.

Other information

STORAGE AND HANDLING SECTION

Store in cool dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Butylene Glycol, Diethyl Azelate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Alcohol, Methyl Hydroxypropyl Cellulose, Polyacrylate Crosspolymer 6, Polysorbate 20, Water

Questions?

OTC - QUESTIONS SECTION

1-833-499-0932 or theralast.com

Company Information

SPL UNCLASSIFIED SECTION

Distributed by Skin Sherpa North America, LLC, 18756 Stone Oak Parkway, Ste. 200San Antonio, TX 78258

www.theralast.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

theralast revised2theralast revised2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80967-003-012024-01-30C16284748780-11030e365-0620-111a-e063-dadaa90a10e2Theralast Maximum Strength Pain Relief Gel
80967-003-032024-01-30C16284748780-11030e365-0620-111a-e063-dadaa90a10e2Theralast Maximum Strength Pain Relief Gel
80967-003-102024-01-30C16284748780-11030e365-0620-111a-e063-dadaa90a10e2Theralast Maximum Strength Pain Relief Gel
80967-003-202024-01-30C16284748780-11030e365-0620-111a-e063-dadaa90a10e2Theralast Maximum Strength Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80967-003-01Theralast Maximum Strength Pain Relief Gel1 in 1 BOXGEL12
80967-003-01Theralast Maximum Strength Pain Relief Gel100 mL in 1 TUBEGEL1002
80967-003-03Theralast Maximum Strength Pain Relief Gel3 in 1 BOXGEL32
80967-003-03Theralast Maximum Strength Pain Relief Gel3 mL in 1 PACKETGEL32
80967-003-10Theralast Maximum Strength Pain Relief Gel10 in 1 BOXGEL102
80967-003-10Theralast Maximum Strength Pain Relief Gel3 mL in 1 PACKETGEL32
80967-003-20Theralast Maximum Strength Pain Relief Gel20 in 1 BOXGEL202
80967-003-20Theralast Maximum Strength Pain Relief Gel3 mL in 1 PACKETGEL32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80967-003THERALAST MAXIMUM STRENGTH PAIN RELIEF GEL (MENTHOL) GEL [SKIN SHERPA NORTH AMERICA LLC]2Legacy NDC, 8 package rows20220322_d8a63dc0-9e21-0bcd-e053-2a95a90a71bd.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80967-00380967-003-01, 80967-003-03, 80967-003-10, 80967-003-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
ALCOHOL3K9958V90MIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
DIETHYL AZELATE4E9QQ39A4XIACT
ISOPROPYL ALCOHOLND2M416302IACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MENTHOLL7T10EIP3AACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT

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
dabd3b95-01d6-014c-e053-2a95a90a0fecd8a63dc0-9e21-0bcd-e053-2a95a90a71bd2022-03-21WarningsExact identifier
spl id: dabd3b95-01d6-014c-e053-2a95a90a0fec
spl set id: d8a63dc0-9e21-0bcd-e053-2a95a90a71bd

Reported adverse events (FAERS/openFDA)#

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