Back Hp

Back Hp
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.

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.**

Section 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.


Structured Label Content

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.

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.

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.**

Section 55106-9 (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.


Advanced Ingredient Data


Raw Label Data

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