Theralast Maximum Strength Pain Relief Gel

Theralast Maximum Strength Pain Relief Gel
SPL v2
SPL
SPL Set ID d8a63dc0-9e21-0bcd-e053-2a95a90a71bd
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
Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) 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 2022-02-22

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?

1-833-499-0932 or theralast.com

Active Ingredient

Menthol 4%

Other Information

Store in cool dry place

Product Packaging

Company Information

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

www.theralast.com

Inactive Ingredients

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

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?

1-833-499-0932 or theralast.com

Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)

Store in cool dry place

Product Packaging

Company Information

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

www.theralast.com

Inactive Ingredients (Inactive ingredients)

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

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


Raw Label Data

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