Label: REAL TIME PAIN RELIEF CREAM- 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 December 29, 2017

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    • 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 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 Extract, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis Extract, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum Extract, Matricaria chamomilla Extract, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata Extract, Triethanolamine.

  • Package Label, Principal Display Panel and Drug Facts

    labeling

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF CREAM 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-600
    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)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EMU OIL (UNII: 344821WD61)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-600-1545 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2013
    2NDC:58133-600-07210 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2013
    3NDC:58133-600-04120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/30/2013
    4NDC:58133-600-12354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/30/2013
    5NDC:58133-600-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/30/2013
    6NDC:58133-600-40120 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2013
    7NDC:58133-600-3398 mL in 1 TUBE; 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(58133-600)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!