menthol davis topical analgesic ointment

menthol davis topical analgesic ointment
SPL v1
SPL
SPL Set ID b809ccd5-c5de-4bb4-b8e9-7a1402208989
Route
topical
Published
Effective Date 2022-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (50 mg)
Inactive Ingredients
paraffin petrolatum

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2023-09-04

Purpose

Topical Analgesic

Description

Menthol 5%


Medication Information

Warnings

For external use only.

Purpose

Topical Analgesic

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.
Other Information

Store in a cool, dry, ventilated place, away from all sources of heat, ignition, and combustion.

Inactive Ingredients

Paraffin wax, petrolatum.

Description

Menthol 5%

Use

For the temporary relief of minor aches and pains of muscles and joints

Active Ingredient

Menthol 5%

Package Labeling:

When Using This Product
  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
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

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.

Purpose

Topical Analgesic

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.
Other Information (Other information)

Store in a cool, dry, ventilated place, away from all sources of heat, ignition, and combustion.

Inactive Ingredients (Inactive ingredients)

Paraffin wax, petrolatum.

Use

For the temporary relief of minor aches and pains of muscles and joints

Active Ingredient (Active ingredient)

Menthol 5%

Package Labeling:

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
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

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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