Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 79c21a7b-ffb7-4b0d-a702-8aec0463be81
Route
ORAL
Published
Effective Date 2018-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (3 [hp_X]) Apis Mellifera (6 [hp_X]) Chloride Ion (8 [hp_X]) Histamine (10 [hp_X]) Ledum Palustre Twig (12 [hp_X]) Sulfur (16 [hp_X]) Copaifera Officinalis Resin Lytta Vesicatoria Croton Tiglium Seed Graphite Daphne Mezereum Bark Kerosene Toxicodendron Vernix Leafy Twig Delphinium Staphisagria Seed Antipyrine
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-12-06 Until 2028-12-20

Description

Calendula Officinalis 3X, Apis Mellifica 6X, Natrum Muriaticum 6X, Urtica Urens 6X, Histaminum Hydrochloricum 6X, 12X, 30X, Ledum Palustre 6X, 12X, 30X, Sulphur 8X, Copaiva Officinalis 10X, Cantharis 12X, Croton Tiglium 12X, Graphites 12X, Mezereum 12X, Petroleum 12X, Rhus Venenata 12X, Staphysagria 12X, Antipyrinum 16X.


Medication Information

Description

Calendula Officinalis 3X, Apis Mellifica 6X, Natrum Muriaticum 6X, Urtica Urens 6X, Histaminum Hydrochloricum 6X, 12X, 30X, Ledum Palustre 6X, 12X, 30X, Sulphur 8X, Copaiva Officinalis 10X, Cantharis 12X, Croton Tiglium 12X, Graphites 12X, Mezereum 12X, Petroleum 12X, Rhus Venenata 12X, Staphysagria 12X, Antipyrinum 16X.

Warnings:

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

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

Tamper seal: "Sealed for Your Protection."

Do not use if seal is broken or missing.

Questions:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients:

Calendula Officinalis 3X, Apis Mellifica 6X, Natrum Muriaticum 6X, Urtica Urens 6X, Histaminum Hydrochloricum 6X, 12X, 30X, Ledum Palustre 6X, 12X, 30X, Sulphur 8X, Copaiva Officinalis 10X, Cantharis 12X, Croton Tiglium 12X, Graphites 12X, Mezereum 12X, Petroleum 12X, Rhus Venenata 12X, Staphysagria 12X, Antipyrinum 16X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

DESBIO

NDC 43742-1413-1

HOMEOPATHIC

ITCH

FORMULA

1 FL OZ (30 ml)

Homeopathic Indications:

For the temporary relief of symptoms related to itching, such as hives, itching at night, intolerable scratching, insect bites, poison ivy exposure, skin irritation, dry skin, and lice.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Keep Out of Reach of Children:

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.


Structured Label Content

Warnings: (WARNINGS:)

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

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

Tamper seal: "Sealed for Your Protection."

Do not use if seal is broken or missing.

Questions: (QUESTIONS:)

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

Directions: (DIRECTIONS:)

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Calendula Officinalis 3X, Apis Mellifica 6X, Natrum Muriaticum 6X, Urtica Urens 6X, Histaminum Hydrochloricum 6X, 12X, 30X, Ledum Palustre 6X, 12X, 30X, Sulphur 8X, Copaiva Officinalis 10X, Cantharis 12X, Croton Tiglium 12X, Graphites 12X, Mezereum 12X, Petroleum 12X, Rhus Venenata 12X, Staphysagria 12X, Antipyrinum 16X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

DESBIO

NDC 43742-1413-1

HOMEOPATHIC

ITCH

FORMULA

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For the temporary relief of symptoms related to itching, such as hives, itching at night, intolerable scratching, insect bites, poison ivy exposure, skin irritation, dry skin, and lice.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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