Otc - Active Ingredient
Tea Tree Oil 4.9%
Scratched
FDA Label NDC 71157-0021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kelada Creative Group for the product Scratched (NDC 71157-0021). 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, warnings, indications & usage, dosage & administration, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
First aid to help prevent infection and for temporary relief of discomfort from minor cuts and scratches
Warnings
For external use only
Do not use other than as directed
When using this product
- avoid contact with eyes and mucous membranes
- consult with doctor before applying on post-surgical sites
Indications & Usage
First aid to help prevent infection and for temporary relief of discomfort from minor cuts and scratches​
Dosage & Administration
Adults and children 3 years of age and older; lightly apply to affected area not more than 5 times daily
Children under 3 years of age; ask a doctor
Otc - 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.
Inactive Ingredient
Organic sunflower oil, Beeswax, Organic extra virgin olive oil, Organic comfrey leaf, Kaolin clay, Spanish Rosemary essential oil, Natural Vitamin E
Package Label.Principal Display Panel
Scratched (Scratched)
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