Menstrual Comfort

Dosage form: cream
Ingredients: MENTHOL 5g in 100g
Labeler: Transitions for Health dba Emerita
NDC Code: 62280-134

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Emerita Menstrual Comfort Cream

Active Ingredient:   Menthol 5%

Purpose:  Topical Analgesic

USES

   temporarily relieves minor pain associated with

  • Menstrual cramps  
  • lower backache
  • muscle strains
  • arthritis

Warnings

 for external use only

WHEN USING THIS PRODUCT

  •   use only as directed
  •   do not bandage tightly or use with a heating paD
  •   avoid contact with eyes or mucous membranes
  •   do not apply to wounds or damaged skin



STOP USE AND ASK A DOCTOR IF

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops


IF PREGNANT OR BREAST-FEEDING     ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:
  • squeeze desired amount of Menstrual Comfort pain relieving cream onto affected area
  • massage onto affected area
  • repeat as necessary, but no more than 4 times daily
children 12 years and younger:
  • ask a doctor

INACTIVE INGREDIENTS

Water(purified), Tocopheryl Acetate (Vit E), Isopropyl Palmitate, Stearic Acid, Glyceryl Stearate, Cetyl Alchohol, Olea Europaea(Olive) Fruit Oil, Sodium Magnesium Silicate, Sodium Behenoyl Lactylate, Aloe Barbedensis(Aloe Vera) Leaf Juice, Eucalyptus Globulus Leaf oil, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinales(Rosemary) Leaf Oil, Mentha Virdis (Spearmint) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Valeriana Officinalis Rhizome/Root Extract, Viburmum Prunifolium (Cramp Bark) Extract, Allantoin, Bisabolol, Champhor, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid

MENSTRUAL COMFORT  
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62280-134
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM SILICATE 
ALOE VERA LEAF 
ALLANTOIN 
ISOPROPYL PALMITATE 
OLIVE OIL 
GLYCERYL MONOSTEARATE 
RHIZOPUS ARRHIZUS VAR. ARRHIZUS 
CETYL ALCOHOL 
STEARIC ACID 
ALPHA-TOCOPHEROL 
BEHENETH-10 
SPEARMINT OIL 
EUCALYPTUS OIL 
LAVENDER OIL 
SAGE 
ROSEMARY 
VALERIAN 
VIBURNUM PRUNIFOLIUM BARK 
LEVOMENOL 
CAMPHOR (SYNTHETIC) 
PHENOXYETHANOL 
GLYCERYL OLEATE 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:62280-134-011 TUBE (TUBE) in 1 CARTON
1NDC:62280-134-0056 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/31/200905/01/2013
Labeler - Transitions for Health dba Emerita (008086832)

Revised: 04/2013
 
Transitions for Health dba Emerita

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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