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Drug Facts
Instant Hand Sanitizer
FDA Label NDC 57685-7110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apex Sanitation, Llc for the product Instant Hand Sanitizer (NDC 57685-7110). 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 other, active ingredient, purpose, use, warnings, otc - do not use, otc - stop use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl Alcohol 66.5%
Purpose
Antiseptic
Use
For handwashing to decrease bacteria on skin without soap and water.
Warnings
For external use only. Flammable, keep away from fire or flame.
Otc - Do Not Use
Do not use in eyes, if this happens, rinse thoroughly with water.
Otc - Stop Use
Stop use, ask doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.
Directions
- wet hands & wrists thoroughly with product and allow to dry without wiping
Inactive Ingredients
aloe vera, carbomer, D&C green # 5, D&C yellow # 10, fragrance, purified water, triethanolamine
Principal Display Panel – Pouch
NDC 57685-7110-0
APEX
ANTISEPTIC
Instant Hand
Sanitizer
Fresh Scent
with Aloe Vera
0.0570 fl.oz. (1.68 mL)
MFD for APEX SANITATION, LLC.
Detroit, MI 48228 800-281-1878
www.ApexAntiseptic.com
Principal Display Panel – Pouch (Ape03 0000 01)
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