Label: PAIN RELIEF CREAM TOPICAL ANALGESIC- menthol 6% cream

  • 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 October 31, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 6.0%

  • 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 this product

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

    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 Juice, Anthemis nobilis (Roman Chamomile), Arnica montana, Butylene glycol, Calendula officinalis (Marigold), Capryl glycol, Calpsicum grutescens, Carbomer, Cantharius tinctorious (Safflower) Seed Oil, Centaureacyanus (Cornflower), Cetearyl alcohol, Cetyl alcohol, Chamomila recutita (Matricaria Chamomila), Coriandrum sativum (Coriander), Hamamelis virginiana (Witch Hazel), Bark/Leaf/Twig, Hypericum perforatum (St. John's Wort), Industrial Hemp geed oil, Methylsulfonylmethane, Phenoxyethanol, Purified water,Salix alba (Willow Bark), SD Alcohol40, Sorbitol, Tetrasodium EDTA, Tilla cordata (Lime Tree), Triethanolamine

  • SPL UNCLASSIFIED SECTION

    Manufactured for: Good Energy Products

    a DBA of Special Effort Ltd. Austin, TX 78701

    www.goodenergyproducts.com (800) 698-ALOE

    Made in the U.S.A.

  • PRINCIPAL DISPLAY PANEL

    PDP Drtug facts

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM  TOPICAL ANALGESIC
    menthol 6% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TRIETHANOLAMINE LAURYLAMINOPROPIONATE (UNII: 793J74ICPW)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPSICUM (UNII: 00UK7646FG)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SORBITOL (UNII: 506T60A25R)  
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    HEMP (UNII: TD1MUT01Q7)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    3-((3-CHLOROPHENYL)(4-(METHYLSULFONYL)PHENYL)METHYLENE)DIHYDRO-2(3H)-FURANONE, (3Z)- (UNII: 920350682Z)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-222-0381 mL in 1 TUBE; Type 0: Not a Combination Product10/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/31/2018
    Labeler - Cosmetic Specialty labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty labs, Inc.032973000manufacture(58133-222)
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