4KIDS BUMPS N BRUISES WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, AND RUTA GRAVEOLENS FLOWERING TOP) OINTMENT [HYLAND'S]

4KIDS BUMPS N BRUISES WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, AND RUTA GRAVEOLENS FLOWERING TOP) OINTMENT [HYLAND'S]
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NDC 54973-3210-1
Set ID df3f0398-e8c0-4fc7-a551-032cfbab4d16
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Arnica Montana 2X HPUSpain, swelling, bruising, soreness, sensitivity to touch
    Bellis Perennis 6X HPUSsoreness
    Hypericum Perforatum 3X HPUSpain, bruising, soreness
    Ruta Graveolens 6X HPUSaching pain, swelling, bruised sensation, soreness
  • Uses

    Temporarily relieves the symptoms of pain, swelling, bruising, soreness and sensitivity to touch.

  • Warnings

    For external use only. Do not take by mouth. Keep out of eyes.

    Do not use on broken skin.

    Stop use and ask doctor if rash occurs.

    Keep this and all medications out of the reach of children.

    If swallowed, get medical help or call a Poison Control Center right away. Do not use if seal is broken.

    In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Wash affected area with lukewarm water and apply freely as needed, or as recommended by a licensed health care provider. Do not use on broken skin.

  • Other information

    Protect this product from excessive heat and direct sunlight.

  • Inactive ingredients

    Beeswax, Candelilla Wax, Carnauba Wax, Glycerine, Jojoba Oil, Lecithin, Lemongrass Oil, Olive Oil, Rosemary Oil, Tocopherol, Water, White Thyme Oil.

  • PRINCIPAL DISPLAY PANEL - 22.68 g Tube Blister Pack

    NDC 54973-3210-1

    Bumps 'n Bruises ®

    with Arnica

    Safe & Effective Relief*

    Bruising • Pain • Swelling

    0.8 OZ (22.68g) OINTMENT STICK

    Carton

  • INGREDIENTS AND APPEARANCE
    4KIDS BUMPS N BRUISES WITH ARNICA 
    arnica montana, bellis perennis, hypericum perforatum, and ruta graveolens flowering top ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA2 [hp_X]  in 1 g
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS6 [hp_X]  in 1 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    SPANISH THYME OIL (UNII: U14667H96E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3210-11 in 1 BLISTER PACK05/28/2015
    122.68 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/28/2015
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3210) , pack(54973-3210)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources622559110manufacture(54973-3210) , pack(54973-3210)

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