scar

scar
SPL v2
SPL
SPL Set ID f83f2234-24dc-4fb9-972e-ada049d940ed
Route
oral
Published
Effective Date 2023-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calendula officinalis flowering top (6 [hp_C]) graphite hypericum perforatum delphinium staphisagria seed silicon dioxide allylthiourea
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2015-04-01

Description

ACTIVE INGREDIENTS (HPUS*): Calendula 10X, 6C, Graphites 10X, 6C, Hypericum Perforatum 10X, 6C, Staphysagria 10X, 6C, Silicea 10X, 6C, Thiosinaminum 10X, 6C


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*): Calendula 10X, 6C, Graphites 10X, 6C, Hypericum Perforatum 10X, 6C, Staphysagria 10X, 6C, Silicea 10X, 6C, Thiosinaminum 10X, 6C

Indications and Usage

USES: Aids in the reduction of scar tissue.**

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*): Calendula 10X, 6C, Graphites 10X, 6C, Hypericum Perforatum 10X, 6C, Staphysagria 10X, 6C, Silicea 10X, 6C, Thiosinaminum 10X, 6C

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:43406-0527-1

Scar

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: Aids in the reduction of scar tissue.**


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*): Calendula 10X, 6C, Graphites 10X, 6C, Hypericum Perforatum 10X, 6C, Staphysagria 10X, 6C, Silicea 10X, 6C, Thiosinaminum 10X, 6C

Indications and Usage (34067-9)

USES: Aids in the reduction of scar tissue.**

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.

**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:43406-0527-1

Scar

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: Aids in the reduction of scar tissue.**


Advanced Ingredient Data


Raw Label Data

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