Omeoformula 3 Tissue Tone

OMEOFORMULA®3-TISSUE TONE (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Skin slackening

1.2.    Tissue revitalization

1.3.    Gluteal muscle tone.

2. DOSAGE AND ADMINISTRATION

2.1.    Treatment for IM application: 1 vial 1-3 times a week according to severity and clinic evolution.

2.2.    Treatment using mesotherapy technique: Apply 0.3 ml for each point. Using a 13 mm, 30G or a 4 mm, 27G needle, make the classic intradermal injections utilizing mesotherapy technique.

Application points: Apply to the affected area (abdomen, upper and lower extremities, gluteus muscles). Gluteus muscles:  from the center of the gluteus muscle proceed along 4 injection lines, in a sunburst shape; apply along the subgluteal furrow.

Standard protocol consists of one session a week for 5-7 weeks. For prolonged treatments, 2 sessions for the first week, 1 session a week for 1 month and then 1 session a month are recommended.


Discard unused solution.


2.3.    Opening of Vials: Use sterile needles and sterile syringe. Do not reuse. Do not use if foreign particles are present. Draw 1 cc of air into syringe, insert needle into vial inject air and withdraw the solution into the syringe

3. DOSAGE FORMS AND STRENGTHS

3.1.    Injectable solution for subcutaneneous, intradermal, or intramuscular  administration.

Pharmaceutical forms: 2 ml glass vials.

3.2.    Each ingredient is attenuated according to the Homeopathic Pharmacopea of United States.

Active ingredients: a-Ketoglutaricum acidum 6X; Barium oxalosuccinate 6X; Calcarea carbonica 6X; Calcarea carbonica 30X; Calcarea carbonica 200X; Cis-Aconitic acid 6X; Citricum acidum 6X; Cyclamen europaeum 6X; DL malic acid 6X; Embryo  6X; Fumaricum acidum 6X; Funiculus umbilicalis 6X; Isoleucine 6X; Leucine 6X; Lysine 6X; Magnesium gluconate 6X; Manganum phosphoricum 6X; Methionine 6X; Natrum pyruvicum 6X; Natrum sulphuricum 6X; Nicotinamidum 6X; Phenylalanine 6X; Placenta 10X; Pulsatilla 6X; Succinicum acidum 6X; Threonine 6X; Thuja occidentalis 6X; Tryptophan 6X; Valine 6X.

Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to OMEOFORMULA®3-TISSUE TONE. However patients with a known hypersensitivity to any ingredient should be tested before use. Make a spot injection (0.1ml) into the forearm and observe for any reactions for 1 hour.

5. WARNINGS AND PRECAUTIONS

5.1.    Be sure to disinfect the area before application. Skin disinfection helps avoid infection at the site of administration that can result from saprophytic bacteria (i.e. atypical mycobacteria, staphylococcus genus) that may be present on the skin.

6. ADVERSE REACTIONS

6.1.    The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema.

7. DRUG INTERACTIONS

7.1.    None Known.

8. USE IN SPECIFIC POPULATIONS

8.1    Pregnancy:  Pregnancy  category  C.  Animal  reproduction  studies  have  not  been conducted  with  OMEOFORMULA®3-TISSUE TONE.  OMEOFORMULA®3-TISSUE TONE  should  not  be  administered  to  a pregnant woman. 

8.2    Nursing mothers:    It is not known whether any of the ingredients in OMEOFORMULA®3-TISSUE TONE  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when OMEOFORMULA®3-TISSUE TONE is administered to a nursing woman.

8.3    Pediatric use: Effectiveness in pediatric patients has not been established.

8.4    Geriatric use: No restrictions.

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

OMEOFORMULA®3- TISSUE TONE is a sterile solution made with isotonic sodium chloride solution. Its formulation is based on classical Homeopathy and each ingredient has been selected according to the homeopathic description as referred to in  Materia Medica.

The firming and toning activity is due to the activity of the suis-organ ingredients.  The amino acid ingredients promote protein synthesis.

12. CLINICAL PHARMACOLOGY

12.1.    Mechanism of Action

The medication acts through a low-dose enzymatic mechanism.

12.2.    Pharmacodynamics

The physiological effects of OMEOFORMULA®3- TISSUE TONE      are  due to  the effects of the ingredients, according to their description in the Homeopathic Materia Medica.

12.3.    Pharmacokinetics

Homeopathic attenuation  provides complete bioavability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    OMEOFORMULA®3- TISSUE TONE has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    OMEOFORMULA®3- TISSUE TONE formulation is based  on classical Homeopathy and each ingredient has been selected according to the homeopathic description as referred in Materia Medica.

15. REFERENCES

15.1.    E.Italia, M. De Bellis: Manuale di Omeo-mesoterapia – Guna Ed. 1995

15.2.    H.H. Reckeweg: Homeopathic Materia medica omeopatica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC 17089-274-31  10 glass vial packed in carton box

16.2.    NDC 17089-274-32  50 glass vial packed in carton box

16.3.    Store at room temperature, 20-25°C (68-77° F). Avoid  freezing  and  excessive  heat.

17. PATIENT COUNSELING INFORMATION

17.1.    Patients should be informed of the homeopathic approach and the therapeutic goals of OMEOFORMULA®3- TISSUE TONE.

PACKAGE LABEL

OMEOFORMULA 3-TISSUE TONE   .alpha.-ketoglutaric acid - aconitic acid, cis - barium cation - calcium carbonate - citric acid monohydrate - cyclamen purpurascens tuber - fumaric acid - isoleucine - leucine - lysine - magnesium gluconate - malic acid - manganese phosphate, dibasic - methionine - natrum sulphuricum - niacinamide - phenylalanine - pulsatilla vulgaris - sodium pyruvate - succinic acid - sus scrofa placenta - sus scrofa umbilical cord - threonine - thuja occidentalis twig - tryptophan - valine - sus scrofa embryo -   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17089-274 Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .ALPHA.-KETOGLUTARIC ACID (.ALPHA.-KETOGLUTARIC ACID) .ALPHA.-KETOGLUTARIC ACID 6 [hp_X]  in 2 mL BARIUM OXALOSUCCINATE (BARIUM OXALOSUCCINATE) BARIUM OXALOSUCCINATE 6 [hp_X]  in 2 mL CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 30 [hp_X]  in 2 mL ACONITIC ACID, CIS- (ACONITIC ACID, CIS-) ACONITIC ACID, CIS- 6 [hp_X]  in 2 mL CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) CITRIC ACID MONOHYDRATE 6 [hp_X]  in 2 mL CYCLAMEN PURPURASCENS TUBER (CYCLAMEN PURPURASCENS TUBER) CYCLAMEN PURPURASCENS TUBER 6 [hp_X]  in 2 mL MALIC ACID (MALIC ACID) MALIC ACID 6 [hp_X]  in 2 mL SUS SCROFA EMBRYO (SUS SCROFA EMBRYO) SUS SCROFA EMBRYO 6 [hp_X]  in 2 mL FUMARIC ACID (FUMARIC ACID) FUMARIC ACID 6 [hp_X]  in 2 mL SUS SCROFA UMBILICAL CORD (SUS SCROFA UMBILICAL CORD) SUS SCROFA UMBILICAL CORD 6 [hp_X]  in 2 mL ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 6 [hp_X]  in 2 mL LEUCINE (LEUCINE) LEUCINE 6 [hp_X]  in 2 mL LYSINE (LYSINE) LYSINE 6 [hp_X]  in 2 mL MAGNESIUM GLUCONATE (MAGNESIUM CATION) MAGNESIUM GLUCONATE 6 [hp_X]  in 2 mL MANGANESE PHOSPHATE, DIBASIC (MANGANESE PHOSPHATE, DIBASIC) MANGANESE PHOSPHATE, DIBASIC 6 [hp_X]  in 2 mL Methionine (Methionine ) Methionine 6 [hp_X]  in 2 mL SODIUM PYRUVATE (PYRUVIC ACID) SODIUM PYRUVATE 6 [hp_X]  in 2 mL SODIUM SULFATE (SODIUM CATION) SODIUM SULFATE 6 [hp_X]  in 2 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 6 [hp_X]  in 2 mL PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 6 [hp_X]  in 2 mL SUS SCROFA PLACENTA (SUS SCROFA PLACENTA) SUS SCROFA PLACENTA 10 [hp_X]  in 2 mL PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 6 [hp_X]  in 2 mL SUCCINIC ACID (SUCCINIC ACID) SUCCINIC ACID 6 [hp_X]  in 2 mL THREONINE (THREONINE) THREONINE 6 [hp_X]  in 2 mL THUJA OCCIDENTALIS TWIG (THUJA OCCIDENTALIS TWIG) THUJA OCCIDENTALIS TWIG 6 [hp_X]  in 2 mL TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 6 [hp_X]  in 2 mL VALINE (VALINE) VALINE 6 [hp_X]  in 2 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.018 mL  in 2 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-274-31 10 VIAL In 1 BOX contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-274-31) 2 17089-274-32 50 VIAL In 1 BOX contains a VIAL, GLASS 2 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-274-32)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/29/2006

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Operations
Guna spa		430538264	manufacture

Revised: 06/2010Guna spa