Active Ingredient(S)
Ethyl alcohol 75% v/v. Purpose: Antiseptic
Helios Hand Sanitizer
FDA Label NDC 74140-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pretty Woman Llc for the product Helios Hand Sanitizer (NDC 74140-200). 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 ingredient(s), purpose, use, 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
Antiseptic, Hand Sanitizer
Use
- to decrease bacteria on the skin that could 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
- 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
- conditions persists more that 72h
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
Directions
- wet hands thoroughly with product and allow to dry without wiping
- for children under 6 years of age, use only under adult supervision
- not recommended for infants
Other Information
Other information
- store below 104°F (40°C)
- may discolor certain fabrics or surfaces
Inactive Ingredients
acrylates copolymer, aminomethyl propanol, fragrance, glycerin, water
Package Label - Principal Display Panel
80 mL NDC: 74140-200-01
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