Label: THERMAL-AID HEADACHE RELIEF- bryonia alba root and toxicodendron pubescens leaf cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 30, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Bryonia 6x HPUS 0.1%Muscle aches and stiffness
    Rhus Toxicodendron 6x HPUS 0.1%Muscle pain and stiffness
  • Uses

    External analgesic for temporary relief of headache and migraine pain.

  • Warnings

    For external use only. Avoid contact with eyes and open wounds.

    Stop use and ask a doctor if condition persists for more than 7 days or worsens.

    Keep out of reach of children. In case of ingestion, seek professional assistance or contact a poison control center.

  • Directions

    Adults and children age 12 and older: Apply a small amount of cream to forehead and temples, and massage into skin. Use as needed and when headache pain flares up.

  • Other Information

    Store at 68 to 77 degrees Fahrenheit.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Steric Acid, Polysorbate 60, Cocos Nucifera (Coconut) Oil, Cetyl Alcohol, Cetearyl Alcohol, Propylene Glycol, Mineral Oil, Myristyl Myristate, Glycine Soja (Soybean) Oil, Sodium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Menthol, Tocopheryl Acetate, Squalene, Soluble Collagen, Hydrolyzed Elastin, Allium Sativum (Garlic) Bulb Extract, Glycerin, Caprylhydroxamic Acid, Benzyl Alcohol.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Pacific Shore Holdings, Inc.
    Chatsworth, CA 91311

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Label

    thermal-AID®

    Headache Relief Cream
    Fast, Safe, Powerful Relief You Can Count On

    NET WT 2 OZ. (57g)

    PRINCIPAL DISPLAY PANEL - 57 g Tube Label
  • INGREDIENTS AND APPEARANCE
    THERMAL-AID   HEADACHE RELIEF
    bryonia alba root and toxicodendron pubescens leaf cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69314-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 57 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SQUALENE (UNII: 7QWM220FJH)  
    HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)  
    GARLIC (UNII: V1V998DC17)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69314-201-4257 g in 1 TUBE; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC08/01/2019
    Labeler - Pacific Shore Holdings, Inc. (809755148)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855MANUFACTURE(69314-201)
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