REAL TIME PAIN RELIEF VEGAN SELECT (MENTHOL) LOTION [COSMETIC SPECIALTY LABS, INC.]

REAL TIME PAIN RELIEF VEGAN SELECT (MENTHOL) LOTION [COSMETIC SPECIALTY LABS, INC.]
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NDC 58133-555-03, 58133-555-12
Set ID 62fb27de-beb4-8bed-e053-2991aa0a6ae1
Category HUMAN OTC DRUG LABEL
Packager Cosmetic Specialty Labs, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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