Active Ingredient
Benzalkonium Chloride 0.13%
Lidocaine HCl 0.5%
First Shield
FDA Label NDC 49314-0003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product First Shield (NDC 49314-0003). 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, purpose, uses, warnings, do not use, 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
Purpose
First aid antiseptic
Topical analgesic
Uses
- temporary relief of pain associated with minor burns
- helps protect against harmful bacteria
Warnings
For external use only.
Do Not Use
- in eyes
- in large quantities
- over raw surfaces or blistered areas, or on deep puncture wounds, animal bites, serious burns
- for more than one week unless directed by a doctor
Keep Out Of Reach Of Children.
If ingested, get medical help or contact a Poison Control Center right away.
Directions
- clean affected area
- apply a small amount not more than 3-4 times daily
- children under 2 years: do not use,consult a doctor
Other Information
- store at room temperature (do not freeze)
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive Ingredients
aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA,ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol,purified water, PEG-100 Stearate, phenoxyethanol, stearic acid, triethanolamine
Questions Or Comments?
1-800-480-5855
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