Cold Sore Complex
FDA Label NDC 52731-7029

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nova Homeopathic Therapeutics, Inc. for the product Cold Sore Complex (NDC 52731-7029). 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 purpose:, usage and dosage:, dosage & administration, warnings:, warnings, active ingredients:, inactive ingredients:, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Purpose:

→ Usage And Dosage:

→ Dosage & Administration

→ Warnings:

→ Warnings

→ Active Ingredients:

→ Inactive Ingredients:

→ Otc - Questions

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Purpose:

Suggested use for one or more of the following symptoms:

Fever blisters, canker sores, cracked lips, scabs on chin and mouth.

Usage And Dosage:

For oral use only.

Dosage & Administration

Adults:

    In Acute Phase:
        12-15 drops until relief occurs
    When Relief Occurs:
          12-15 drops, 4-6 times per day

Children 2-12 years:

            8-10 drops, 4-6 times per day

Infants 0-24 months:

          4 drops, 4-6 times per day