Theralast Topical Analgesic Relief Gel

Manufacturer
SKIN SHERPA NORTH AMERICA LLC
Effective date
2022-02-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:08:09

Label at a glance#

ProductTheralast Topical Analgesic Relief
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 Nonanedioate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Alcohol, Hypromellose, Polysorbate 20, Water

Questions?

OTC - QUESTIONS SECTION

Call (210) 281-1056 MON-FRI 9AM-5PM CST

Company Information

SPL UNCLASSIFIED SECTION

Distributed by Skin Sherpa North America, LLC, San Antonio, TX 78216

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THERALAST

TOPICAL ANALGESIC

RELIEF

GEL

LASTS UP TO 8 HOURS

FAST ACTING

DEEP PENETRATING

NON-GREASY APPLICATION

PHYSICIAN

RECOMMENDED

PATIENT

APPROVED

TERANONA®

MOLECULAR TECHNOLOGY

3.4 FL OZ (100 ML)

Performance claims based on patient surveys

theralasttheralast

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80967-00180967-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
d8b2417c-5d4f-8e48-e053-2a95a90abe6db42da9ec-fefd-bb40-e053-2a95a90aff872022-02-23WarningsExact identifier
spl id: d8b2417c-5d4f-8e48-e053-2a95a90abe6d
spl set id: b42da9ec-fefd-bb40-e053-2a95a90aff87

Reported adverse events (FAERS/openFDA)#

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