Injury

Injury
SPL v2
SPL
SPL Set ID b4b850fb-6fdd-47b7-8a6e-2e596ec6256c
Route
ORAL
Published
Effective Date 2022-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (6 [hp_X]) Comfrey Root (12 [hp_X]) Arnica Montana (30 [hp_X]) Bellis Perennis Bryonia Alba Root Hypericum Perforatum Ledum Palustre Twig Phosphorus Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Delphinium Staphisagria Seed Rancid Beef
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-01-14

Description

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Calendula Officinalis 6X, Symphytum Officinale 6X, Arnica Montana 12X, Bellis Perennis 12X, Bryonia Alba 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Phosphorus 12X, Rhus Toxicodendron 12X, Ruta Graveolens 12X, Staphysagria 12X, Pyrogenium 30X


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 soreness, and/or aching feeling.**

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: Calendula Officinalis 6X, Symphytum Officinale 6X, Arnica Montana 12X, Bellis Perennis 12X, Bryonia Alba 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Phosphorus 12X, Rhus Toxicodendron 12X, Ruta Graveolens 12X, Staphysagria 12X, Pyrogenium 30X

Section 34093-5

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

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

Section 50565-1

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:43406-0603-1

Injury

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

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

Section 55105-1

USES: Temporarily relieves minor soreness, and/or aching feeling.**

Section 55106-9

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Calendula Officinalis 6X, Symphytum Officinale 6X, Arnica Montana 12X, Bellis Perennis 12X, Bryonia Alba 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Phosphorus 12X, Rhus Toxicodendron 12X, Ruta Graveolens 12X, Staphysagria 12X, Pyrogenium 30X


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves minor soreness, and/or aching feeling.**

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.

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

Section 50565-1 (50565-1)

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:43406-0603-1

Injury

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

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 soreness, and/or aching feeling.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Calendula Officinalis 6X, Symphytum Officinale 6X, Arnica Montana 12X, Bellis Perennis 12X, Bryonia Alba 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Phosphorus 12X, Rhus Toxicodendron 12X, Ruta Graveolens 12X, Staphysagria 12X, Pyrogenium 30X


Advanced Ingredient Data


Raw Label Data

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