Active Ingredient(S)
Zinc oxide 1%
Cold Sore Bandage Patch
FDA Label NDC 87308-003
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 Hengdasheng Technology Co., Ltd for the product Cold Sore Bandage (NDC 87308-003). 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 ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - 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
Purpose
Skin Protection
Use
Promotes the healing of cold sores, covering and protecting the affected area from bacterial infection.
Warnings
For external use only
Avoid contact with eyes
Flammable
Keep away from heat or flame
Do Not Use
If you are allergic to any of the ingredients
On broken skin unless directed by a doctor
Otc - When Using
Do not use with other topical products on the same area unless directed by a doctor.
Otc - Stop Use
Irritation occurs or discomfort persists.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply at the first sign of cold sore symptoms (tingling, itching or pain)
Clean and dry the affected area
Take out a cold sore patch
Gently press and seal the patch to the affected area
Wash your hands after applying the patch
Replace the patch every 8 to 12 hours, or sooner if it loosens
Other Information
Store in a cool, dry place
Cold sores are contagious. Avoid sharing personal items that contact the cold sore
Wash your hands before and after touching the cold sore or applying the patch
If you are pregnant or breastfeeding, please consult a healthcare professional before use
Inactive Ingredients
Mineral Oil, Cellulose Gum, Polyisobutene, Lysine, Calendula Officinalis,Tocopheryl Acetate, Melaleuca Alternifolia (Tea Tree) Leaf Oil
Package Label - Principal Display Panel
Undefined (Label)
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