Label: ARTHRITIS PAIN RELIEF- histamine dihydrochloride .025% cream

  • Category: HUMAN OTC DRUG LABEL

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 November 29, 2022

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  • ACTIVE INGREDIENT

    Histamine Dihydrochloride 0.025%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains & bruises.

  • WARNINGS

    For external use only

    Do not use on wounds or damaged skin or if you are allergic to ingredients in the products

    When using this product

    Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.

    Do not bandage tightly or use a heating pad.

    Stop use and ask a doctor if

    Rash appears.

    Condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

    If pregnant or breast- feeding, ask a health professional before use.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    For Use by Adult and Children over 12 years of age.

    Apply a thin layer to the pain site and message until thoroughly absorbed into skin.

    Apply no more than 3 to 4 times daily.

    Children 12 years or younger consult a physician

  • OTHER SAFETY INFORMATION

    Store between 68°C and 77° F (20° and 25° C)

  • INACTIVE INGREDIENT

    Acrylates/Acrylamide Copolymer )and) Mineral Oil (and) Polysorbate 85, Cetyl Alcohol, Chondroitin Sulfate, Dimethicone, disodium EDTA, Emu Oil, Glucosamine HCl, Glycerin, Helianthus Annus (Sunflower) Extract, Isopropyl Palmitate, Methyl Sulfonyl Methane (MSM), Phenoxyethanol, Propylene Glycol, Stearic Acid, Tocopheryl Actate, Triethanolamine, Water

  • PRINCIPAL DISPLAY PANEL

    Package Carton

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEF 
    histamine dihydrochloride .025% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EMU OIL (UNII: 344821WD61)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHONDROITIN SULFATE (PORCINE) (UNII: V5E8ELO4W9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3035-251 in 1 CARTON11/01/2022
    1113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2022
    Labeler - Walgreens (008965063)
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