Comforte Menstrual Cramp Relief Cream

Comforte Menstrual Cramp Relief Cream
SPL v3
SPL
SPL Set ID c121537e-3333-4f35-8c77-20086158dff4
Route
TOPICAL
Published
Effective Date 2022-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Shea Butter Sunflower Oil Lavender Oil Sandalwood Oil Turmeric

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-02-01 Until 2028-10-30

Description

Menthol 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 4%

Uses

Temporarily relieves minor pain associated with cramps

Warnings

For external use only

if prone to allergic reaction from aspirin or salicylates, consult a doctor before use Allergy alert:

Directions

adults and children over 12 years: 

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin 
  • repeat as necessary, but no more than 4 times daily 
  • ask a doctor children 12 years or younger;
Drug Facts

Questions?

Call 877.590.6257

Active Ingredient

Menthol 4%

Package Labeling:

Inactive Ingredients

Shea Butter, Carapa Procera Oil, Sunflower Oil, Lavendar Oil, Calotropis Procera Extract, Sandalwood Oil, Red Cabbage Juice, Turmeric,  Monoglyceride, Diglyceride

When Using This Product
  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucuous membranes
  • do not apply to wounds or damaged skin.
Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

Temporarily relieves minor pain associated with cramps

Purpose

Topical analgesic

Warnings

For external use only

if prone to allergic reaction from aspirin or salicylates, consult a doctor before use Allergy alert:

Directions

adults and children over 12 years: 

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin 
  • repeat as necessary, but no more than 4 times daily 
  • ask a doctor children 12 years or younger;
Drug Facts

Questions?

Call 877.590.6257

Active Ingredient (Active ingredient)

Menthol 4%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Shea Butter, Carapa Procera Oil, Sunflower Oil, Lavendar Oil, Calotropis Procera Extract, Sandalwood Oil, Red Cabbage Juice, Turmeric,  Monoglyceride, Diglyceride

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucuous membranes
  • do not apply to wounds or damaged skin.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs.
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.)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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