PAIN RELIEF- ruta graveolens cream

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Homeopathic medication manufactured, distributed, or labeled by Active Release Techniques LLC, Leo Desilets maitre herboriste Inc/Facotek Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PAIN RELIEF  
ruta graveolens cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76029-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	3 [hp_X]  in 50 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76029-001-02	50 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/01/2011

Labeler - Active Release Techniques LLC (174462593)

Registrant - Active Release Techniques LLC (174462593)

Establishment
Name	Address	ID/FEI	Business Operations
Leo Desilets maitre herboriste Inc/Facotek Packaging		245423439	manufacture