Unda Numbers

Unda Numbers
SPL v6
SPL
SPL Set ID 2044a04e-275f-3f16-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2015-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silver (12 [hp_X]) Filipendula Ulmaria Root (4 [hp_X]) Crataegus Fruit Tin Valerian Gelsemium Sempervirens Root Hamamelis Virginiana Bark Magnolia Grandiflora Flower Antimony Trisulfide Borage Cetraria Islandica Subsp. Islandica Drosera Rotundifolia Flowering Top Mentha Piperita Polygala Senega Root Manganese Dioxide Sage Peumus Boldus Leaf Matricaria Recutita Jateorhiza Calumba Root Wormwood Aconitum Napellus Coffea Arabica Seed, Roasted Gold Solanum Dulcamara Top Fagopyrum Esculentum Star Anise Fruit Arctium Lappa Root Sarsaparilla Delphinium Staphisagria Seed Viola Tricolor
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-09-21

Description

Active ingredients Each drop contains: Argentum metallicum (Silver) 12X Aurum metallicum (Gold) 12X Dulcamara (Bittersweet) Shoots 4X Fagopyrum esculentum Aerial Parts 4X Illicium verum (Star Anise) Fruit 4X Lappa major (Great burdock) Root 4X Salvia officinalis (Garden sage) Leaf 4X Sarsaparilla Root 4X Staphysagria (Stavesacre) Seed 12X Viola tricolor (Pansy) Aerial Parts 4X


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage

Uses

For the temporary relief of symptoms associated with mild skin irritation.

Directions

Adults and adolescents (12 years and older): Take 5 drops three times daily or as

recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your

healthcare practitioner.

Dosage and Administration

Directions

Adults and adolescents (12 years and older): Take 5 drops three times daily or as

recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your

healthcare practitioner.

Description

Active ingredients Each drop contains: Argentum metallicum (Silver) 12X Aurum metallicum (Gold) 12X Dulcamara (Bittersweet) Shoots 4X Fagopyrum esculentum Aerial Parts 4X Illicium verum (Star Anise) Fruit 4X Lappa major (Great burdock) Root 4X Salvia officinalis (Garden sage) Leaf 4X Sarsaparilla Root 4X Staphysagria (Stavesacre) Seed 12X Viola tricolor (Pansy) Aerial Parts 4X

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if symptoms persist or worsen.

Section 50569-3

Ask a doctor before use if you have Persistent cough or chronic cough

such as occurs with smoking, asthma, chronic bronchitis, or emphysema and Cough that is accompanied by

excessive phlegm (mucus) or fever.

Section 51727-6

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4

NDC 62106-1152-8

UNDA

numbered compounds

UNDA 12

Homeopathic Preparation

For the temporary relief of symptoms

associated with mild skin irritation.

Contains 31% Alcohol

0.7 fl oz (20 ml)

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Uses

For the temporary relief of symptoms associated with mild skin irritation.

Section 55106-9

Active ingredients

Each drop contains:

Argentum metallicum (Silver) 12X

Aurum metallicum (Gold) 12X

Dulcamara (Bittersweet) Shoots 4X

Fagopyrum esculentum Aerial Parts 4X

Illicium verum (Star Anise) Fruit 4X

Lappa major (Great burdock) Root 4X

Salvia officinalis (Garden sage) Leaf 4X

Sarsaparilla Root 4X

Staphysagria (Stavesacre) Seed 12X

Viola tricolor (Pansy) Aerial Parts 4X

Section 60561-8

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of symptoms associated with mild skin irritation.

Directions

Adults and adolescents (12 years and older): Take 5 drops three times daily or as

recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your

healthcare practitioner.

Dosage and Administration (34068-7)

Directions

Adults and adolescents (12 years and older): Take 5 drops three times daily or as

recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your

healthcare practitioner.

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist or worsen.

Section 50569-3 (50569-3)

Ask a doctor before use if you have Persistent cough or chronic cough

such as occurs with smoking, asthma, chronic bronchitis, or emphysema and Cough that is accompanied by

excessive phlegm (mucus) or fever.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4 (51945-4)

NDC 62106-1152-8

UNDA

numbered compounds

UNDA 12

Homeopathic Preparation

For the temporary relief of symptoms

associated with mild skin irritation.

Contains 31% Alcohol

0.7 fl oz (20 ml)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

For the temporary relief of symptoms associated with mild skin irritation.

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Argentum metallicum (Silver) 12X

Aurum metallicum (Gold) 12X

Dulcamara (Bittersweet) Shoots 4X

Fagopyrum esculentum Aerial Parts 4X

Illicium verum (Star Anise) Fruit 4X

Lappa major (Great burdock) Root 4X

Salvia officinalis (Garden sage) Leaf 4X

Sarsaparilla Root 4X

Staphysagria (Stavesacre) Seed 12X

Viola tricolor (Pansy) Aerial Parts 4X

Section 60561-8 (60561-8)

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.


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