Otc - Active Ingredient
ACTIVE INGREDIENTS
ORGANIC SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)
ORGANIC ECHINACEA ANGUSTIFOLIA (2X) HPUS
ORGANIC CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)
PINUS SILVESTRIS (1X) HPUS (PINE RESIN)
THUJA OCCIDENT (6X) HPUS
Cold Sore Free
FDA Label NDC 52810-301
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puremedy for the product Cold Sore Free (NDC 52810-301). 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, otc - purpose, indications & usage, dosage & administration, inactive ingredient, warnings, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PROPERTIES
ANTI-INFLAMMATORY
ANTI-VIRAL
SKIN PROTECTANT
SKIN PROTECTANT
RELIEF FOR SKIN ERUPTIONS OR BURNING PAIN
Indications & Usage
USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH HERPETIC OUTBREAKS, COLD SORES AND CANKER SORES. USE ORALLY OR GENITALLY.
Dosage & Administration
DIRECTIONS: APPLY TO AFFECTED AREA 3-8 TIMES PER DAY AS NEEDED. MAY BE APPLIED GENITALLY. ALSO APPLY DAILY AS A PREVENTIVE MEASURE.
Inactive Ingredient
OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, BALSAM FIR, WILD HARVESTED DRAGONS BLOOD (SANGRE DE GRADO).
Warnings
WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Other Safety Information
STORE IN A COOL DRY PLACE OR REFRIGERATE
* Please review the disclaimer below.
