CUTIS COMPOSITUM- ledum palustre twig, urtica urens, aesculus hippocastanum flower, galium aparine, strychnos ignatii seed, arctium lappa root, phosphoric acid, sus scrofa skin, thuja occidentalis leafy twig, fumaric acid, sus scrofa umbilical cord, sus scrofa adrenal gland, pork liver, .alpha.-ketoglutaric acid, sodium diethyl oxalacetate, sus scrofa placenta, selenium, sus scrofa spleen, sulfur, calcium fluoride, mercurius solubilis, cortisone acetate, thallium sulfate, ichthammol and formic acid solution 
Heel Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Cutis compositum oral vial

DESCRIPTION

Each 2.2 ml ampule contains: 

Ingredient Name

Potency

Quantity

Aesculus hippocastanum

6x

22µ

a-Ketoglutaricum acidum

10x

22µ

Calcarea fluorica

13x

22µ

Cortisone aceticum

28x

22µ

Cutis suis

8x

22µ

Formicum acidum

10x

22µ

Fumaricum acidum

198x

22µ

Funiculus umbilicals suis

10x

22µ

Galium aparine

6x

22µ

Glandula suprarenalis

10x

22µ

Hepar suis

10x

22µ

Ichthyolum

28x

22µ

Ignatia amara

6x

22µ

Lappa major

6x

22µ

Ledum palustre

4x

22µ

Mercurius solubilis

13x

22µ

Natrum oxalaceticum

10x

22µ

Phosphoricum acidum

6x

22µ

Placenta suis

10x

22µ

Selinium metallicum

10x

22µ

Splen suis

10x

22µ

Sulfur

10x

22µ

Thallium sulphuricum

13x

22µ

Thuja occidentalis

8x

22µ

Urtica urens

4x

22µ


Inactive Ingredient: Isotonic Sodium Chloride solution

INDICATION AND USAGE

Cutis compositum® Oral Vials is a homeopathic drug product is indicated for the temporary relief of persistent skin conditions such as acne, eczema, and allergic dermatitis

DOSAGE AND ADMINISTRATION

Dosage:

Adults and children above 6 years: 1 vial orally 1-3 times daily

Children up to 6 years: ½ vial orally 1-3 times daily

CONTRAINDICATIONS

Cutis compositum®Oral Vials  are contraindicated in patients with known hypersensitivity to Cutis compositum® or any of its ingredients

WARNINGS AND PRECAUTIONS

Warnings and Precautions

None

ADVERSE REACTIONS

No adverse events have been reported with a causal relationship to Cutis compositum® Oral Vials

OVERDOSAGE

Overdosage: No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions

CLINICAL PHARMACOLOGY

Mechanism of Action

The exact mechanism of Cutis compositum® Oral Vials is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 oral vial containing 2.2ml solution for oral administration

Cutis compositum oral vial.jpg

CUTIS COMPOSITUM 
ledum palustre twig, urtica urens, aesculus hippocastanum flower, galium aparine, strychnos ignatii seed, arctium lappa root, phosphoric acid, sus scrofa skin, thuja occidentalis leafy twig, fumaric acid,sus scrofa umbilical cord,sus scrofa adrenal gland,pork liver,.alpha.-ketoglutaric acid, sodium diethyl oxalacetate,sus scrofa placenta,selenium,sus scrofa spleen,sulfur,calcium fluoride, mercurius solubilis,thallium sulfate,cortisone acetate, ichthammol, formic acid, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50114-5170
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG4 [hp_X]  in 2.2 mL
URTICA URENS (URTICA URENS) URTICA URENS4 [hp_X]  in 2.2 mL
AESCULUS HIPPOCASTANUM FLOWER (AESCULUS HIPPOCASTANUM FLOWER) AESCULUS HIPPOCASTANUM FLOWER6 [hp_X]  in 2.2 mL
GALIUM APARINE (GALIUM APARINE) GALIUM APARINE6 [hp_X]  in 2.2 mL
STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED6 [hp_X]  in 2.2 mL
ARCTIUM LAPPA ROOT (ARCTIUM LAPPA ROOT) ARCTIUM LAPPA ROOT6 [hp_X]  in 2.2 mL
PHOSPHORIC ACID (PHOSPHORIC ACID) PHOSPHORIC ACID6 [hp_X]  in 2.2 mL
SUS SCROFA SKIN (SUS SCROFA SKIN) SUS SCROFA SKIN8 [hp_X]  in 2.2 mL
THUJA OCCIDENTALIS LEAFY TWIG (THUJA OCCIDENTALIS LEAFY TWIG) THUJA OCCIDENTALIS LEAFY TWIG8 [hp_X]  in 2.2 mL
FUMARIC ACID (FUMARIC ACID) FUMARIC ACID10 [hp_X]  in 2.2 mL
SUS SCROFA UMBILICAL CORD (SUS SCROFA UMBILICAL CORD) SUS SCROFA UMBILICAL CORD10 [hp_X]  in 2.2 mL
SUS SCROFA ADRENAL GLAND (SUS SCROFA ADRENAL GLAND) SUS SCROFA ADRENAL GLAND10 [hp_X]  in 2.2 mL
PORK LIVER (PORK LIVER) PORK LIVER10 [hp_X]  in 2.2 mL
.ALPHA.-KETOGLUTARIC ACID (.ALPHA.-KETOGLUTARIC ACID) .ALPHA.-KETOGLUTARIC ACID10 [hp_X]  in 2.2 mL
SODIUM DIETHYL OXALACETATE (DIETHYL OXALACETATE) SODIUM DIETHYL OXALACETATE10 [hp_X]  in 2.2 mL
SUS SCROFA PLACENTA (SUS SCROFA PLACENTA) SUS SCROFA PLACENTA10 [hp_X]  in 2.2 mL
SELENIUM (SELENIUM) SELENIUM10 [hp_X]  in 2.2 mL
SUS SCROFA SPLEEN (SUS SCROFA SPLEEN) SUS SCROFA SPLEEN10 [hp_X]  in 2.2 mL
SULFUR (SULFUR) SULFUR10 [hp_X]  in 2.2 mL
CALCIUM FLUORIDE (FLUORIDE ION) CALCIUM FLUORIDE13 [hp_X]  in 2.2 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS13 [hp_X]  in 2.2 mL
CORTISONE ACETATE (CORTISONE) CORTISONE ACETATE28 [hp_X]  in 2.2 mL
THALLIUM SULFATE (SULFATE ION) THALLIUM SULFATE13 [hp_X]  in 2.2 mL
ICHTHAMMOL (ICHTHAMMOL) ICHTHAMMOL28 [hp_X]  in 2.2 mL
FORMIC ACID (FORMIC ACID) FORMIC ACID198 [hp_X]  in 2.2 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-5170-610 in 1 CARTON
12.2 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/199308/18/2014
Labeler - Heel Inc (102783016)

Revised: 8/2014
Document Id: b2b23b24-2a39-4a6c-8de8-28c86a227be3
Set id: 59124471-398f-4438-ab72-ec12ab50f421
Version: 2
Effective Time: 20140818
 
Heel Inc