Active Ingredients
Docosanol 10%-------------Cold sore / fever blister treatment
Ishancare Cold Sore Treatment Gel
FDA Label NDC 73076-164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Ishan Technology Co., Ltd for the product Ishancare Cold Sore Treatment (NDC 73076-164). 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 active ingredients, inactive ingredients, uses, warnings, when using this product, stop use, ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Light mineral oil, Sucrose stearate, Propylene glycol, Purified water.
Uses
For the temporary relief of pain and itching associated with cold sores and fever blisters. Relieves dryness and softens cold sores and fever blisters.
Warnings
Allergy Test-Apply a small amount of this cold sore product behind the ear or on the inner wrist.Check for allergic reactionssuch as itching,redness,orrash within 48hours.If any occur, discontinue use and seek medical help immediately.For external use only do
not useif you are allergic to anyingredient in this product.
When Using This Product
apply only to affected areas, do not use in or near theeyes, avoid applying directly inside your mouth, do not share this product with anyone, this may spread infection.
Stop Use
if your cold sore gets worse or the cold soreis not healed within 10 days.
Ask A Doctor
if your cold sore gets worse or the cold soreis not healed within 10 days.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage And Administration
Wash hands before and after applying, adults and children12 years of age
and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years
of age: Consult a doctor.
Other Information
Store a troom temperature and avoid excessive heat
Directions:
Wash hands before and after applying, adults and children12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Consult a doctor.
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