Otc - Active Ingredient
Ethyl alcohol 62%
Spectrum 62% Hand Sanitizer Gel
FDA Label NDC 53329-214
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 62% Hand Sanitizer (NDC 53329-214). 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, dosage & administration, 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
- to decrease bacteria on
- recommended for repeated use
the skin that could cause disease
Warnings
- For external use only: hands
- Flammable. Keep away from heat and flame.
Otc - When Using
- 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
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- wet hands
- for children under 6, use only
- not recommended for infants
thoroughly with product and
allow to dry without wiping
under adult supervision
Other Safety Information
- do not store above 105OF
- may discolor some fabrics
- harmful to wood finishes and plastics
Inactive Ingredient
- Aloe barbadensis leaf juice
- carbomer
- diisopropylamine
- glycerin
- isopropyl myristate
- propylene glycol
- tocopheryl
- acetate
- water
* Please review the disclaimer below.
