Active Ingredients (V/V)
Ethyl Alcohol 70%
Hand Sanitizer Gel
FDA Label NDC 77955-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Custom Chemicial Solutions for the product Hand Sanitizer (NDC 77955-003). 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 active ingredients (v/v), purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Uses
- To decrease bacteria on the skin that can cause disease
- Recommended for repeated use
Warnings
For external use only: hands
Flammable. Keep away from fire or flame.
Otc - When Using
When using this product avoid contact with eyes.
In case of eye contact, flush eyes with water.
Avoid contact with broken skin.
Do not ingest or inhale.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Pump enough product into palm of hand to thoroughly cover all surfaces of both hands.
Rub hands together briskly until dry.
For children under 6, use only under adult supervision
Other Information:
Store below 110 F (43 C).
May discolor some fabrics.
May be harmful to wood finishes and plastics.
Inactive Ingredients:
Water (Eau), Triisopropanolamine, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Fragrance (Parfum), Isopropyl Myristate, Tocopheryl Acetate, Denatonium Benzoate.
Package Label.Principal Display Panel
HAND SANITIZER
Contains 70% alcohol
500 mL (16.9 US fl.oz)
Manufactured for:
Custom Chemical Solutions, LLC
167 Commerce Dr.
Loveland, OH 45140 USA
* Please review the disclaimer below.
