SPL v2
SPL
SPL Set ID 0da55dbd-907a-41fe-9c1c-b0c91fb04be9
Route
TOPICAL
Published
Effective Date 2011-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ruta Graveolens Flowering Top (3 [hp_X])
Inactive Ingredients
Argan Oil Yellow Wax Benzoic Acid Calendula Officinalis Flowering Top Cetearyl Olivate Dehydroacetic Acid Diethylene Glycol Monoethyl Ether Glycerin Isopropyl Palmitate Potassium Citrate Ribes Nigrum Seed Oil Sambucus Nigra Flower Sodium Hydroxide Sorbitan Olivate Tea Tree Oil Water Xanthan Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-04-01

Description

Ruta Graveolens 3X


Medication Information

Warnings and Precautions

for external use only

Indications and 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.

Dosage and 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



Description

Ruta Graveolens 3X

Section 50565-1

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

Section 50566-9

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



Section 50567-7

When using this product

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

Section 50570-1

Do not use

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

Section 51727-6

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

Section 51945-4

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

Safe and Effective

Non-Greasy and Odor Free

Section 53414-9

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

Section 55105-1

Topical Analgesic

Section 55106-9

Ruta Graveolens 3X


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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



Warnings and Precautions (34071-1)

for external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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



Section 50567-7 (50567-7)

When using this product

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

Section 50570-1 (50570-1)

Do not use

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Safe and Effective

Non-Greasy and Odor Free

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Ruta Graveolens 3X


Advanced Ingredient Data


Raw Label Data

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