Purpose
Antibacterial
Antibacterial Wipes
FDA Label NDC 78494-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fitguard for the product Antibacterial Wipes (NDC 78494-003). 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 purpose, active ingredient:, inactive ingredients:, uses:, warnings:, directions:, instructions for use:, fitguard antibacterial wipes, 800 count, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Benzalkonium Chloride 0.30%
Inactive Ingredients:
Water, Phenoxyethanol, DMDM Hydantoin, Polysorbate 20, Ethylparaben, Methylparaben, Fragrance, Disodium EDTA, Sodium Citrate, Cetylpyridinium Chloride
Uses:
For skin surface sanitizing to decrease bacteria.
Warnings:
For external use only.
May irritate eyes.
Keep out of reach of children unless under adult supervision.
Keep out of reach of children unless under adult supervision.
Directions:
Important! Do not open the top of the bag.
1. Cut a 1" opening into the top center of the bag along dashed line.
2. Pull out the center wipe from the bag through the 1" hole.
3. Place the bag of wipes into the dispenser.
4. Thread the center wipe through the hole in the top of the dispenser.
Instructions For Use:
Take single sheets as needed and apply topically to clean skin.
* Please review the disclaimer below.
