Label: MEIJER PAIN RELIEVING BALM ANALGESIC- trolamine salicylate cream

  • NDC Code(s): 41250-356-01
  • Packager: Meijer Distribution, 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 January 21, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Trolamine Salicylate 10%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

    Allergy Alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    • Avoid contact with eyes
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly
    • Do not use with heating pads or heating devices
    • If condition worsens, or if the symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

    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 6 years of age and older apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: Do Not Use.

  • Other information

    Store at room temperature

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, arnica montana flower extract, boswellia carterii oil, butyrospermum parkii (shea) butter, calophyllum inophyllum seed oil, caprylic/capric triglyceride, cetyl alcohol, curcuma longa (turmeric) root extract, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate, harpagophytum procumbens root extract, isopropyl palmitate, macadamia ternifolia seed oil, menthol, olea europaea (olive) fruit oil, PEG-100 stearate, phenoxyethanol, propylene glycol, salix alba (willow) bark extract, sodium hyaluronate, sodium hydroxide, sodium PCA, stearic acid, theobroma cacao (cocoa) seed butter, water.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DIST. BY
    MEIJER DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544

  • PRINCIPAL DISPLAY PANEL - 113 g Jar Label

    meijer®

    TURMERIC INFUSED
    pain relieving balm
    Trolamine Salicylate 10%

    Topical Analgesic

    WITH TURMERIC,
    BOSWELLIA OIL, TAMANU OIL
    AND DEVIL'S CLAW

    Helps relieve minor aches and pains
    of muscles and joints associated with:

    • backache
    • bruises
    • arthritis
    • sprains
    • strains

    NET WT 4 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Jar Label
  • INGREDIENTS AND APPEARANCE
    MEIJER PAIN RELIEVING BALM   ANALGESIC
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-356
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Trolamine Salicylate (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) Trolamine Salicylate10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    TURMERIC (UNII: 856YO1Z64F)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-356-01113 g in 1 JAR; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34804/30/2020
    Labeler - Meijer Distribution, INC (006959555)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(41250-356)
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