FDA Label for Ziclovin Oral Pain Relief
View Indications, Usage & Precautions
Ziclovin Oral Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| Active ingredients | Purposes |
| Benzalkonium chloride 0.1%........................ | Topical antiseptic |
| Benzocaine 20%.......................................... | Fever blister and cold sore treatment |
Uses
For the temporary relief of pain due to
- fever blisters
- cold sores
- antiseptic to help prevent infection
Warnings
For external use only. Avoid contact with the eyes.
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics
Do Not Use
- longer than 1 week
- on large areas of the body
- in the eyes
Ask A Doctor Before Use
- in case of deep or puncture wounds, animal bites, or serious burns
When Using This Product
- you may feel a brief stinging sensation after application that will go away shortly thereafter
Stop Use And Ask A Dentist Or Doctor If
- a rash or irritation develops
- condition persists or worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older: Clean the affected area. Apply a small amount to affected not more than 3 times daily. May be covered with a sterile bandage. If bandaged, let first dry.
- children under 2 years of age: do not use, consult a doctor
Other Information
- store between 68-77°F (20-25°C)
Inactive Ingredients
ammonium glycyrrhizate, carboxymethylcellulose sodium, FD&C yellow #6, glycerin, polyethylene glycol, saccharin sodium, sorbic acid, water
Questions?
Dist. by/por: PHARMADEL LLC
New Castle, DE 19720
Questions? +1-866-359-3478
* Please review the disclaimer below.
