Cold Sore Hp
FDA Label NDC 43406-0013

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc. for the product Cold Sore Hp (NDC 43406-0013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, dosage & administration, otc - do not use, references, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS (HPUS*): Juglans Cinerea 30C, Kali Iodatum 30C, Lycopodium Clavatum 30C, Mercurius Vivus 30C, Natrum Muriaticum 30C, Nitricum Acidum 30C, Phosphorus 30C, Ranunculus Bulbosus 30C, Rhus Toxicodendron 30C, Sepia 30C, Thuja Occidentalis 30C

Indications & Usage

USES: Temporarily relieves pustules, skin ulcerations, dry cracked skin with soreness, &/or symptoms related to herpes sores.

Warnings

WARNING:

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.

Dosage & Administration

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

Otc - Do Not Use

OTHER INFORMATION: Tamper Seal: "Sealed for your protection."

Do not use if seal is broken or missing.

References

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

Inactive Ingredient

INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

Otc - Questions

QUESTIONS AND COMMENTS?

MFG FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600

LOT:

Otc - Purpose

USES: Temporarily relieves pustules, skin ulcerations, dry cracked skin with soreness, &/or symptoms related to herpes sores.

Otc - Keep Out Of Reach Of Children

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

Package Label.Principal Display Panel

NDC: 43406-0013-1

COLD SORE HP

Cold Sores

1 fl oz (30 mL) / 20% Ethanol

UPC: 877730000965

Image Of Label (Coldsorehp)

Image Of Label (Coldsorehp)

* Please review the disclaimer below.