Label: REAL TIME PAIN RELIEF VEGAN SELECT- menthol lotion

  • 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 January 17, 2018

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  • Active Ingredient

    Menthol 1.25%

  • 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 this product

    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
  • 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

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    ​adults and children over 2 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

    children 2 years or younger: ask a doctor

  • Inactive ingredients:

    Aloe Barbadensis Leaf, Anthemis nobilis, Arnica Montana Flower Extract, Butylene Glycol , Calendula officinalis, Caprylyl Glycol, Capsicum Frutescens Fruit Extract, Carbomer, Centaurea cyanus, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Fragrance, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum, Matricaria chamomilla, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Rubus Idaeus (Raspberry) Seed Oil, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tilia cordata, Triethanolamine.

  • Package Label, Principal Display Panel and Drug Facts

    labeling

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF VEGAN SELECT 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CAPSICUM FRUTESCENS WHOLE (UNII: 6XJX33L87P)  
    ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)  
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    3,4-METHYLENEDIOXYBENZYL METHYLSULFONE (UNII: 4W601CSX19)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBITOL (UNII: 506T60A25R)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)  
    RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-555-0390 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/30/2013
    2NDC:58133-555-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/30/2013
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-555)
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