Label: LUMINA NATURES CREATION UNVEILED- menthol cream

  • NDC Code(s): 58133-591-03
  • 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 3, 2023

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  • Active Incredient

    Menthol, 4%

  • 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 •do not bandage tightly

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

    Keep out of reach of children . If case of accidental ingestion, get medical help or contact a poison Control Center right away.

  • Directions:

    Adults and children 2 years of age and older:•apply generously to affected area •massage into painful area until thoroughly absorbed into skin •repeat as necessary, but no more than 4 time daily

    Children under 2 years of age: ask a doctor

  • Inactive ingredients

    Alcohol, Aloe Barbadensis Leaf Juice, Arnica montana Flower Extract, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cyanocobalamin, Mentha piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Polysorbate-60, Purified Water, Salix alba (Willow) Bark Extract, Sodium Hyaluronate, Sorbitol, Triethanolamine

  • Package Label

    3 oz roll-on

  • INGREDIENTS AND APPEARANCE
    LUMINA NATURES CREATION UNVEILED 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-591
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALCOHOL (UNII: 3K9958V90M)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-591-0390 mL in 1 CYLINDER; Type 0: Not a Combination Product05/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/03/2023
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-591) , pack(58133-591) , label(58133-591)
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