aoak

aoak
SPL v1
SPL
SPL Set ID a75d1f82-703b-48a3-a6a2-a7ed1cdde0af
Route
oral
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
echinacea purpurea whole (2 [hp_X]) sus scrofa adrenal gland (6 [hp_X]) corticotropin (8 [hp_X]) beef liver (12 [hp_X]) croton tiglium seed histamine wood creosote xerophyllum asphodeloides whole toxicodendron diversilobum leaf toxicodendron pubescens leaf urtica dioica subsp. dioica leaf ailanthus altissima fruit
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 1984-08-15

Description

Echinacea purpurea 2X Adrenal 6X ACTH 6X, 30X Liver 6X, 12X Croton tiglium 8X Histaminum hydrochloricum 12X Kreosotum 12X Xerophyllum 12X and all the following at 6X, 12X, 60X, 100X: Rhus diversiloba (poison oak) Rhus toxicodendron (poison ivy) Stinging nettle Sumac


Medication Information

Warnings

Severe symptoms such as difficulty breathing, facial swelling, dizziness, confusion, and hives may be life-threatening and require immediate emergency care. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 to 15 drops up to 3 times per day. For desensitization, begin with 1 to 5 drops daily, increasing to the standard dose gradually to avoid symptom expression; after 1 to 3 months at the standard dose, decrease gradually to a maintenance dose of 10 to 15 drops weekly. Consult a physician for use in children under 12 years of age.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

20% ethanol, purified water.

Description

Echinacea purpurea 2X Adrenal 6X ACTH 6X, 30X Liver 6X, 12X Croton tiglium 8X Histaminum hydrochloricum 12X Kreosotum 12X Xerophyllum 12X and all the following at 6X, 12X, 60X, 100X: Rhus diversiloba (poison oak) Rhus toxicodendron (poison ivy) Stinging nettle Sumac

Label

Est 1985

Professional Formulas

Complementary Health

Poison Ivy/Oak

Homeopathic Remedy

2 FL. OZ. (59 mL)

Section 50565-1

Keep out of the reach of children.

Section 53414-9

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

Section 55105-1

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

For the temporary relief of redness, swelling, stinging, itching of skin, and itching of nose or throat due to sensitivity to poison ivy and poison oak.*

Active Ingredients

Echinacea purpurea 2X

Adrenal 6X

ACTH 6X, 30X

Liver 6X, 12X

Croton tiglium 8X

Histaminum hydrochloricum 12X

Kreosotum 12X

Xerophyllum 12X

and all the following at 6X, 12X, 60X, 100X:

Rhus diversiloba (poison oak)

Rhus toxicodendron (poison ivy)

Stinging nettle

Sumac


Structured Label Content

Warnings (WARNINGS)

Severe symptoms such as difficulty breathing, facial swelling, dizziness, confusion, and hives may be life-threatening and require immediate emergency care. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Directions (DIRECTIONS)

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 to 15 drops up to 3 times per day. For desensitization, begin with 1 to 5 drops daily, increasing to the standard dose gradually to avoid symptom expression; after 1 to 3 months at the standard dose, decrease gradually to a maintenance dose of 10 to 15 drops weekly. Consult a physician for use in children under 12 years of age.

Other Information (OTHER INFORMATION)

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Poison Ivy/Oak

Homeopathic Remedy

2 FL. OZ. (59 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications (INDICATIONS)

For the temporary relief of redness, swelling, stinging, itching of skin, and itching of nose or throat due to sensitivity to poison ivy and poison oak.*

Active Ingredients (ACTIVE INGREDIENTS)

Echinacea purpurea 2X

Adrenal 6X

ACTH 6X, 30X

Liver 6X, 12X

Croton tiglium 8X

Histaminum hydrochloricum 12X

Kreosotum 12X

Xerophyllum 12X

and all the following at 6X, 12X, 60X, 100X:

Rhus diversiloba (poison oak)

Rhus toxicodendron (poison ivy)

Stinging nettle

Sumac


Advanced Ingredient Data


Raw Label Data

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