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SPL v5
SPL
SPL Set ID e589c7a2-0a7b-44ca-835d-ff25c6606152
Route
oral
Published
Effective Date 2025-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aconitum napellus (30 [hp_X]) horse chestnut (30 [hp_C]) colchicum autumnale bulb hypericum perforatum magnesium cation lead toxicodendron pubescens leaf arnica montana
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2016-06-01

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum Napellus 30X, Aesculus Hippocastanum 30X, Colchicum Autumnale 30X, Hypericum Perforatum 30X, Magnesia Phosphorica 30X, Plumbum Metallicum 30X, Rhus Toxicodendron 30X, Arnica Montana 30C.


Medication Information

Warnings and Precautions

WARNINGS:

* Consult a physician for use in children under 12 years of age.

* IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

* KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

* Do not use if TAMPER EVIDENT seal is broken or missing.

Active Ingredient

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum Napellus 30X, Aesculus Hippocastanum 30X, Colchicum Autumnale 30X, Hypericum Perforatum 30X, Magnesia Phosphorica 30X, Plumbum Metallicum 30X, Rhus Toxicodendron 30X, Arnica Montana 30C.

Indications and Usage

USES: Temporarily relieves minor back, limb, & body aches.**

Dosage and Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum Napellus 30X, Aesculus Hippocastanum 30X, Colchicum Autumnale 30X, Hypericum Perforatum 30X, Magnesia Phosphorica 30X, Plumbum Metallicum 30X, Rhus Toxicodendron 30X, Arnica Montana 30C.

Section 34093-5

* The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

LOT:

Section 50565-1

WARNINGS:

* Consult a physician for use in children under 12 years of age.

* IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

* KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Section 51945-4

NDC: 43406-0622-1

BACK HP

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

UPC: 877730004642 NON GMO Logo

Section 53413-1

QUESTIONS & COMMENTS?:

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1

USES: Temporarily relieves minor back, limb, & body aches.**


Structured Label Content

Warnings and Precautions (34071-1)

WARNINGS:

* Consult a physician for use in children under 12 years of age.

* IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

* KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

* Do not use if TAMPER EVIDENT seal is broken or missing.

Active Ingredient (55106-9)

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum Napellus 30X, Aesculus Hippocastanum 30X, Colchicum Autumnale 30X, Hypericum Perforatum 30X, Magnesia Phosphorica 30X, Plumbum Metallicum 30X, Rhus Toxicodendron 30X, Arnica Montana 30C.

Indications and Usage (34067-9)

USES: Temporarily relieves minor back, limb, & body aches.**

Dosage and Administration (34068-7)

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Section 34093-5 (34093-5)

* The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

LOT:

Section 50565-1 (50565-1)

WARNINGS:

* Consult a physician for use in children under 12 years of age.

* IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

* KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Section 51945-4 (51945-4)

NDC: 43406-0622-1

BACK HP

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

UPC: 877730004642 NON GMO Logo

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?:

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1 (55105-1)

USES: Temporarily relieves minor back, limb, & body aches.**


Advanced Ingredient Data


Raw Label Data

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