Otc - Active Ingredient
Active Ingredients Purpose
Isopropyl Alcohol 63-69% by Volume................... Antiseptic
Tintura De Arnica
FDA Label NDC 70242-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dannso Corp./d.b.a. Essential Products for the product Tintura De Arnica (NDC 70242-129). 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, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, 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
Use
May help prevent skin infection in
- minor cuts
- scrapes
- burns
- bruises
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.
Indications & Usage
Antiseptic
For External Use Only
Dosage & Administration
Directions
- clean the affected area
- and dry thoroughly. Apply a thin layer 1 to 3 times daily.
- May be covered with a sterile bandage, let dry first.
Warnings
Warnings For external use only
Avoid Contact with eyes.
When using this product
- do not use on irritated skin, in or near eyes or mocous membranes, on wounds or damaged skin, if prone to allergic reaction
- Fatal if swallowed.
Stop use and ask a doctor if condition persists or gets worse
Inactive Ingredient
Inactive Ingredients Arnica Extract, Isopropyl Alcohol, Deionized Water
Package Label.Principal Display Panel
Label Image (Arnicatincture)
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