thera plus cold therapy pain relieving gel menthol

thera plus cold therapy pain relieving gel menthol
SPL v2
SPL
SPL Set ID 0a462c91-5300-e282-e063-6394a90a4cc2
Route
topical
Published
Effective Date 2023-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (40 mg)
Inactive Ingredients
aloe vera leaf arnica montana flower fd&c blue no. 1 indian frankincense calendula officinalis flower green tea leaf carbomer homopolymer, unspecified type glycerin ilex paraguariensis leaf isopropyl alcohol isopropyl myristate melissa officinalis leaf .alpha.-tocopherol acetate trolamine fd&c yellow no. 5 water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-01

Purpose

Pain Relieving Gel

Description

Menthol 4%


Medication Information

Warnings

For external use only.

Flammable:Keep away from excessive heat or open flame

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Purpose

Pain Relieving Gel

Directions
  • adults and children 2 years of age and older; rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water
Other Information
  • store at 20° - 25°C (68° - 77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients

aloe barbadensis leaf juice, arctium lappa extract, arnica montana flower extract, blue1, boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, triethanoamine, yellow 5, water

Description

Menthol 4%

Active Ingredient

Menthol 4%

Package Labeling:

Questions Or Comments?

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

When Using This Product
  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device
Stop Use and Ask A Doctor If
  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

Flammable:Keep away from excessive heat or open flame

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Purpose

Pain Relieving Gel

Directions
  • adults and children 2 years of age and older; rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water
Other Information (Other information)
  • store at 20° - 25°C (68° - 77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, arctium lappa extract, arnica montana flower extract, blue1, boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, triethanoamine, yellow 5, water

Active Ingredient (Active ingredient)

Menthol 4%

Package Labeling:

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
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 swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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