PAIN RELIEF (RUTA GRAVEOLENS) CREAM [ACTIVE RELEASE TECHNIQUES LLC]

PAIN RELIEF (RUTA GRAVEOLENS) CREAM [ACTIVE RELEASE TECHNIQUES LLC]
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NDC 76029-001-02
Set ID 0da55dbd-907a-41fe-9c1c-b0c91fb04be9
Category HUMAN OTC DRUG LABEL
Packager Active Release Techniques LLC
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Ruta Graveolens 3X

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    for the temporary relief of minor aches, pains, soreness, and stiffness associated with simple backaches, strains, bruises, sprains, dull tearing in bones of the arm and joints of the elbow and arthritis, as per Homeopathic Materia Medica.

  • WARNINGS

    for external use only

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • in large quantities particularly over raw surfaces or blistered areas
    • with a heating pad
  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
    • use only as directed
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • excessive skin irritation occurs

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: apply to affected are not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician


  • INACTIVE INGREDIENT

    Inactive Ingredients

    Argania Spinosa Kernel Oil, Beeswax (Cera Alba), Benzoic Acid, Calendula Officinalis Flower Extract, Cetearyl Olivate, Dehydroacetic Acid, Dromiceius, Ethoxydiglycol, Glycerin, Isopropyl Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Nymphaea Caerulea Flower Extract, Peucedanum Ostruthium Leaf Extract, Potassium Citrate, Ribes Nigrum (Black Currant) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Sambucus Nigra Flower Extract, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Water/Aqua, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Deep Long-Lasting Temporary Relief of Arthritis Pain, Joint and Muscle Pain

    Safe and Effective

    Non-Greasy and Odor Free

    ART Label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  
    ruta graveolens cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76029-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP3 [hp_X]  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76029-001-0250 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2011
    Labeler - Active Release Techniques LLC (174462593)
    Registrant - Active Release Techniques LLC (174462593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Leo Desilets maitre herboriste Inc/Facotek Packaging245423439manufacture

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