Otc - Active Ingredient
Active Ingredients Purpose
SODIUM BORATE .............................. Antifungal
Glycerin ................................................. Moisturizer
Miel Rosada
FDA Label NDC 70242-127
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 Miel Rosada (NDC 70242-127). 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 aliviate mouth ulcers
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
Antifuncgal
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.
- Children under 2 years should consult a physician.
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 Extract of Roses, Honey , FD&C red # 40, Purified Water
Package Label.Principal Display Panel
Label Image (Mielrosada)
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