Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f5d5f4c6-fb92-402e-bc22-c4b80aeb51ea
Route
TOPICAL
Published
Effective Date 2019-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Lanolin Cocoa Butter Coconut Oil Grape Seed Oil Peppermint Oil Croton Lechleri Resin Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-12-09

Description

Menthol 1%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Menthol 1%

Packaging

Directions
  • Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.
Other Information

Store at room temperature 68 to 77°F (20 to 25ºC).

Active Ingredients

Menthol 1%

Inactive Ingredients

Cocoa Butter, Coconut Oil, Croton Lechleri, Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil


Structured Label Content

Purpose

External analgesic

Packaging

Directions
  • Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.
Other Information

Store at room temperature 68 to 77°F (20 to 25ºC).

Active Ingredients (Active ingredients)

Menthol 1%

Inactive Ingredients

Cocoa Butter, Coconut Oil, Croton Lechleri, Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil


Advanced Ingredient Data


Raw Label Data

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