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| Product NDC Code | 90100-221 | ||||
|---|---|---|---|---|---|
| Drug Name | Herstat plus cold sore treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 2604563 | ||||
| Application Number | M017 | ||||
| Labeler Name | Herstat (USA) Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Camphor 3% Menthol 0.1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS Wash hands well before and after applying. Smooth a small amount onto the affected area. Adults and children 2 years of age and older: Apply to the affected area at least 5 times per day. Children between 2 and 12 years of age - Apply with adult supervision. Children under 2 years of age: Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Almond Oil, Beeswax, Castor Seed Oil, Eucalyptus Leaf Oil, Glyceryl Oleate, Glyceryl Rosinate, Olive Oil, Purified Bee Propolis Extract, Thyme Leaf Oil.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES Treats Cold Sores Temporarily relieves pain and itching associated with Cold Sores / Fever Blisters
Purpose
Information about the drug product’s indications for use.PURPOSE Cold Sore / Fever BlisterTreatment Pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.HERSTAT PLUS Cold Sore Treatment Camphor, Menthol CASTOR OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) YELLOW WAX EUCALYPTUS OIL ALMOND OIL PROPOLIS WAX MENTHOL MENTHOL THYME OIL GLYCERYL OLEATE GLYCERYL ROSINATE OLIVE OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Herstat Cold Sore Treatment Herstat® Herstat Cold Sore Treatment 0.7 OZ (2g) Net Weight Carton
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? Questions? Call (307) 201-5478 or go to www.herstat.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if: • Condition worsens. • Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product: When using this product do not use in or around the eyes. Do not use if allergic to bee byproducts. Test on a small area before use. Bee Propolis, Eucalyptus Oil and Thyme Oil may cause skin irritation. Stop use and ask a doctor if: • Condition worsens. • Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Storage and handling
Information about safe storage and handling of the drug product.OTHER Close cap tightly and store in a cool, dry place.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS For external use only. When using this product: When using this product do not use in or around the eyes. Do not use if allergic to bee byproducts. Test on a small area before use. Bee Propolis, Eucalyptus Oil and Thyme Oil may cause skin irritation. Stop use and ask a doctor if: • Condition worsens. • Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API