Otc - Active Ingredient
Active Ingredient
- Ethyl alcohol 85%
Spectrum Hand Sanitizer Gel
FDA Label NDC 53329-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Spectrum Hand Sanitizer (NDC 53329-003). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
- Antiseptic
Indications & Usage
Uses ■ to decrease bacteria on the
skin that could cause disease
■ recommended for repeated use
Warnings
Warnings
For external use only: hands
Flammable. Keep away from heat
and flame.
Otc - When Using
When using this product
■ keep out of eyes. In case of
contact with eyes, flush
thoroughly with water.
■ avoid contact with broken skin
■ do not inhale or ingest
Otc - Stop Use
Stop use and ask a doctor if
■ irritation or redness develops
■ 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.
Other
*Effective at eliminating 99.9999% of
many common harmful germs and
bacteria on average in 15 seconds.
Dosage & Administration
Directions ■ wet hands thoroughly with product and
allow to dry without wiping
■ for children under 6, use only
under adult supervision
Other Safety Information
Other information
■ do not store above 105 degrees F
■ may discolor some fabrics
■ harmful to wood finishes and
plastics
Inactive Ingredient
Inactive ingredients
Acrylates/C10-30 alkyl acrylate
crosspolymer, bisabolol,
cyclomethicone, glycerin,
isohexadecane, myristyl alcohol,
povidone, tetrahydroxypropyl
ethylenediamine, water
Package Label.Principal Display Panel
84 (53329 003 84)
* Please review the disclaimer below.
