Thera Plus Cool & Heat Pain Relieving Gel Menthol

Thera Plus Cool & Heat Pain Relieving Gel Menthol
SPL v2
SPL
SPL Set ID 0a225714-ccb1-4676-e063-6294a90aeeb2
Route
TOPICAL
Published
Effective Date 2023-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (160 mg)
Inactive Ingredients
Capsaicin Glycerin Isopropyl Myristate Propylene Glycol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

Menthol 16%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 16%

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warnings

For external use only.

Test on a small patch of skin before applying generously.

Flammable •keep away from fire or flame

Directions

• adults and children 12 years of age and older: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but no more than 3 to 4 times daily • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor 

Drug Facts

Active Ingredient

Menthol 16%

Other Information
  • store at 20° - 25°C (68° - 77°F)
  • store in a cool dry place away from direct sunlight
Package Labeling:

Inactive Ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, sd alcohol, triethanoamine, water

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 and mucous membranes • do not apply to wounds or damaged skin • do not

bandage tightly • do not use with heating pads or other heating devices • if redness is present, discontinue use and consult a doctor • if skin irritation occurs, discontinue use • a transient burning sensation may occur upon application but generally disappears in several days

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Purpose

Topical analgesic

Warnings

For external use only.

Test on a small patch of skin before applying generously.

Flammable •keep away from fire or flame

Directions

• adults and children 12 years of age and older: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but no more than 3 to 4 times daily • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor 

Drug Facts

Active Ingredient (Active ingredient)

Menthol 16%

Other Information (Other information)
  • store at 20° - 25°C (68° - 77°F)
  • store in a cool dry place away from direct sunlight
Package Labeling:

Inactive Ingredients (Inactive ingredients)

acrylates/c10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, sd alcohol, triethanoamine, water

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 and mucous membranes • do not apply to wounds or damaged skin • do not

bandage tightly • do not use with heating pads or other heating devices • if redness is present, discontinue use and consult a doctor • if skin irritation occurs, discontinue use • a transient burning sensation may occur upon application but generally disappears in several days

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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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