C49

C49
SPL v1
SPL
SPL Set ID ddf4a44f-a919-4bf7-b54d-241ac4c7ffd2
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]) Grindelia Hirsutula Flowering Top (3 [hp_X]) Ranunculus Bulbosus Whole (4 [hp_X]) Urtica Urens Whole (6 [hp_X]) Lytta Vesicatoria (8 [hp_X]) Daphne Mezereum Bark Toxicodendron Pubescens Leaf Xerophyllum Asphodeloides Whole Croton Tiglium Seed
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Echinacea purpurea 2X Grindelia 2X Ranunculus bulbosus 3X Urtica urens 3X Cantharis 4X Mezereum 6X Rhus toxicodendron 6X Xerophyllum 6X Croton tiglium 8X


Medication Information

Description

Echinacea purpurea 2X Grindelia 2X Ranunculus bulbosus 3X Urtica urens 3X Cantharis 4X Mezereum 6X Rhus toxicodendron 6X Xerophyllum 6X Croton tiglium 8X

Label

Est 1985

Professional Formulas

Complementary Health

Poison Ivy Dermatosis Drops

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.

Warnings

Persistent symptoms may be a sign of a serious condition. Consult a doctor immediately if the reaction is severe or widespread, the rash affects the eyes or mouth, or is accompanied by a fever. 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.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Indications

Temporarily relieves rashes, blisters, inflammation, or itching of the skin.*

Other Information

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

Active Ingredients

Echinacea purpurea 2X

Grindelia 2X

Ranunculus bulbosus 3X

Urtica urens 3X

Cantharis 4X

Mezereum 6X

Rhus toxicodendron 6X

Xerophyllum 6X

Croton tiglium 8X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Poison Ivy Dermatosis Drops

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.

Warnings (WARNINGS)

Persistent symptoms may be a sign of a serious condition. Consult a doctor immediately if the reaction is severe or widespread, the rash affects the eyes or mouth, or is accompanied by a fever. 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.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions (DIRECTIONS)

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

Temporarily relieves rashes, blisters, inflammation, or itching of the skin.*

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.

Active Ingredients (ACTIVE INGREDIENTS)

Echinacea purpurea 2X

Grindelia 2X

Ranunculus bulbosus 3X

Urtica urens 3X

Cantharis 4X

Mezereum 6X

Rhus toxicodendron 6X

Xerophyllum 6X

Croton tiglium 8X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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