Thera Plus Extra Strength Muscle Rub Topical Analgesic Gel

Thera Plus Extra Strength Muscle Rub Topical Analgesic Gel
SPL v3
SPL
SPL Set ID 8a3b6adf-afbb-4d77-a19b-a6514ebd3b50
Route
TOPICAL
Published
Effective Date 2024-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (25 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Camphor (synthetic) Dmdm Hydantoin Isopropyl Alcohol Peg-40 Hydrogenated Castor Oil Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-03

Description

Menthol 2.5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 2.5%

Uses

temporarily relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
Warnings

For external use only.

Direction
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor 
Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with an arthritis-like condition
Drug Facts

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Other Information
  • store at room temperature 68° - 72°F (20° - 22°C).
Package Labeling:

Active Ingredients

Menthol 2.5%

Inactive Ingredients

camphor,carbomer, DMDM hydantoin, isoceteth, isopropyl alcohol,PEG-40 hydrogenated castor oil,purified water,sodium hydroxide

When Using This Product
  • avoid contact with eyes and mucous membranes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • excessive skin irritation occurs
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and then occur again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Uses

temporarily relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
Purpose

Topical analgesic

Warnings

For external use only.

Direction
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor 
Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with an arthritis-like condition
Drug Facts

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Other Information (Other information)
  • store at room temperature 68° - 72°F (20° - 22°C).
Package Labeling:

Active Ingredients (Active ingredients)

Menthol 2.5%

Inactive Ingredients (Inactive ingredients)

camphor,carbomer, DMDM hydantoin, isoceteth, isopropyl alcohol,PEG-40 hydrogenated castor oil,purified water,sodium hydroxide

When Using This Product (When using this product)
  • avoid contact with eyes and mucous membranes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • excessive skin irritation occurs
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and then occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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