Label: CONTROL MENSTRUAL CRAMP RELIEF- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 19, 2021

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  • Active Incredient

    Menthol, 3.0%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

  • Warnings

    for external use only

  • WHEN USING

    When using this prodcut• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin

  • STOP USE

    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 develeps

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Directions:

    Adults and children over 12 years:• apply to affected area • massage into painful area until throughly absorbed into skin • repeat as necessary, but no more than 4 time daily

    Children 12 years or younger: ask a doctor

  • Inactive ingredients

    ​Butylene Glycol, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Chamomilla recutita (Matricaria) Flower Extract, Citrus aurantium Dulcis (Sweet Orange) Peel Oil, Cocos nucifera (Coconut) Oil, Creatine, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Stearic Acid, Triethanolamine.

  • Package Label

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    CONTROL MENSTRUAL CRAMP RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SAGE (UNII: 065C5D077J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CREATINE (UNII: MU72812GK0)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-010-0389 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/04/2021
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-010) , pack(58133-010) , label(58133-010) , analysis(58133-010)
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