Theralast Clinical Strength Md3 Topical Analgesic Gel

SPL v2

SPL

SPL Set ID b43a3167-a882-6b6d-e053-2a95a90a68ad

Route

TOPICAL

Published

Effective Date 2020-11-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (40 mg)

Inactive Ingredients

Alcohol Polysorbate 20 Water Hypromellose, Unspecified Diethyl Azelate Isopropyl Alcohol Aloe Vera Leaf Butylene Glycol Arnica Montana Flower Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-11-15

Description

Menthol 4%

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Menthol 4%

Uses

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

simple backache
strains
sprains
bruises
arthritis

Warnings

For external use only.

Directions

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.

Do Not Use

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

Questions?

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

Active Ingredient

Menthol 4%

Other Information

Store in cool dry place

Product Packaging

THERALAST

CLINICAL STRENGTH

MD3

TOPICAL ANALGESIC GEL

RELIEF UP TO 12 HOURS

FAST ACTING

DEEP PENETRATING

NON-GREASY APPLICATION

PHYSICIAN RECOMMENDED

TERANONA® MOLECULAR TECHNOLOGY

3.4 FL OZ (100 ML)

Performance claims based on patient surveys.

Company Information

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

Inactive Ingredients

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

When Using This Product

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

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

ask a health professional before use.

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have

sensitive skin or redness over the affected area

Structured Label Content

Uses

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

simple backache
strains
sprains
bruises
arthritis

Purpose

Topical analgesic

Warnings

For external use only.

Directions

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.

Do Not Use (Do not use)

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

Questions?

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

Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)

Store in cool dry place

Product Packaging

THERALAST

CLINICAL STRENGTH

MD3

TOPICAL ANALGESIC GEL

RELIEF UP TO 12 HOURS

FAST ACTING

DEEP PENETRATING

NON-GREASY APPLICATION

PHYSICIAN RECOMMENDED

TERANONA® MOLECULAR TECHNOLOGY

3.4 FL OZ (100 ML)

Performance claims based on patient surveys.

Company Information

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

Inactive Ingredients (Inactive ingredients)

When Using This Product (When using this product)

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 (Stop use and ask a doctor if)

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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

sensitive skin or redness over the affected area

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIETHYL AZELATE", "unii": "4E9QQ39A4X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)", "unii": "86FQE96TZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache strains sprains bruises arthritis", "Purpose": "Topical analgesic", "Warnings": "For external use only.", "Directions": "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.", "Do not use": "on large areas of the body with other ointments, creams, sprays or liniments with heating pad", "Questions?": "Call (210) 281-1056 MON-FRI 9AM-5PM CST", "Active ingredient": "Menthol 4%", "Other information": "Store in cool dry place", "Product Packaging": "THERALAST CLINICAL STRENGTH MD3 TOPICAL ANALGESIC GEL RELIEF UP TO 12 HOURS FAST ACTING DEEP PENETRATING NON-GREASY APPLICATION PHYSICIAN RECOMMENDED TERANONA® MOLECULAR TECHNOLOGY 3.4 FL OZ (100 ML) Performance claims based on patient surveys.", "Company Information": "Distributed by Skin Sherpa North America, LLC, San Antonio, TX 78216", "Inactive ingredients": "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", "When using this product": "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": "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": "ask a health professional before use.", "Keep out of reach of children.": "If accidentally ingested, get medical help or contact a Poison Control Center immediately.", "Ask a doctor before use if you have": "sensitive skin or redness over the affected area"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:40.569366 · Updated: 2026-03-14T22:59:45.666904