Otc - Active Ingredient
Alcohol 62%. Purpose: Antiseptic
Povidone Iodine 10%. Purpose: Antiseptic
Saniiswab
FDA Label NDC 84456-493
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Polley Med Llc for the product Saniiswab (NDC 84456-493). 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, indications & usage, warnings, otc - do not use, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
Two-step method to clean and sanitize the skin of the inner nostrils
- Cleans with alcohol
- Sanitizes with povidone iodine
Warnings
Flammable, keep away from fire and flames
For external use only
Otc - Do Not Use
Do Not Use:
- In eyes or mouth
- If product is opened or damaged
- If you are allergic to iodine or to any ingredients
Stop use and ask a doctor if redness, pain, or irritation appear and lasts more than 72 hours. Keep out of reach of children.
Dosage & Administration
For adults and children 12 years of age and older only
To be administered by medical personnel
Step 1. Cleaning. Open Step 1 packet and hold handle, inserting one swab tip into each nostril. Swab lower interior lining inside the nose in a circular motion for 30 seconds. Handle guard protects against insertion of swab tip beyond the nostrils. Discard.
Step 2. Sanitizing. Repeat Step 1 with Step 2 packet. Discard.
Storage And Handling
- Protect from excessive moisture
- Avoid freezing and excessive heat above 40 °C (104 °F)
- Store at room temperature 20-25 °C (68-77 °F)
Inactive Ingredient
Water.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Package Label.Principal Display Panel
Package Label (Saniiswab Ai)
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