Label: GUARDANIA PAIN- capsaicin 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 August 10, 2017

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  • Drug Facts:
  • Active Ingredient:

    Capsaicin 0.025%

    Purpose

    Topical Analgesic

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  • Indications:

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

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  • 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.

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  • 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.

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  • Additional Information:

    Store at room temperature.

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  • 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

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    GUARDANIA PAIN 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71659-842
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71659-842-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/10/2017
    Labeler - LHP Pharma, Inc (080702471)
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