Arc Skin Protectant Ointment
FDA Label NDC 69148-001
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anjon Biologics, Inc for the product Arc Skin Protectant (NDC 69148-001). 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 arc skin protectant ointment, active ingredient / purpose, otc - purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient / Purpose
Otc - Purpose
Allantoin 0.5% .............................. Skin Protectant
Use
- temporarily protects minor burns
Warnings
For external use only
Do not use on
- deep or puncture wounds
- animal bites
- serious burns When using this product
- do not get into eyes. Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- your skin shows significant sign of irritation or discomfort
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply as needed
Other Information
- Keep in a cool place or out of direct sunlight
Inactive Ingredients
aloe vera leaf gel, benzoic acid, benzyl alcohol, cetyl alcohol, citric acid, coconut oil, glycenn, imidazolidinyl urea, isopropyl mylistate, jojoba seed oil, methylisothiazolinone, mineral water, shea butter, sorbitan histearate, vitamin A, vitamin E acetate
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