Label: CONTROL MENSTRUAL CRAMP RELIEF- menthol cream

  • NDC Code(s): 58133-010-01
  • Packager: Cosmetic Specialty Labs, Inc.
  • 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 May 24, 2023

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  • Active Ingredient

    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 product 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

  • PREGNANCY 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. 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 Monohydrate, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Sodium Laureth Sulfate, Stearic Acid, Triethanolamine.

  • Package label

    Control

  • 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)  
    WATER (UNII: 059QF0KO0R)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURETH-4 (UNII: 6HQ855798J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SAGE OIL (UNII: U27K0H1H2O)  
    CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-010-017.5 mL in 1 PACKET; Type 0: Not a Combination Product05/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/24/2023
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-010)
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