GUARDANIA PAIN (CAPSAICIN) CREAM [LHP PHARMA, INC]

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GUARDANIA PAIN (CAPSAICIN) CREAM [LHP PHARMA, INC]
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NDC 71659-842-01
Set ID 84db196d-daf9-46f6-810a-f1aa48bf763a
Category HUMAN OTC DRUG LABEL
Packager LHP Pharma, Inc
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts:

  • Active Ingredient:

    Capsaicin 0.025%

    Purpose

    Topical Analgesic

  • Indications:

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

  • Warnings:

    •For external use only.

    •Avoid contact with eyes.

    •If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    •If swallowed, consult physician.

    •Do not apply to wounds or damaged skin.
    •Do not bandage tightly.

    If pregnant or breast feeding

    contact physician prior to use.

  • Directions:

    •Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    •Children under two-years of age: consult a physician.

  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Acrylates C10/30 Alkyl Acrylate Crosspolymer. Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    GUARDANIA PAIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71659-842
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71659-842-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/10/2017
    Labeler - LHP Pharma, Inc (080702471)
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