Active Ingredient
Alcohol 70% v/v. Purpose: Antiseptic
Hand Sanitizer Gel
FDA Label NDC 74391-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Califormulations Llc for the product Hand Sanitizer Gel (NDC 74391-003). 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 ingredient, 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
Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame
Otc - When Using
When using this product
- Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water
- Avoid contact with broken skin
- Do not inhale or ingest
Otc - Stop Use
Stop use and ask a doctor if
- irritation and redness develop
- condition persist 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
- Wet hands thoroughly wit product to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product.
- Not recommended for infants.
Other Information
- Avoid freezing and excessive heat above 40C (104F)
- May discolor certain fabrics or surfaces
Inactive Ingredients
Water, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Triethanolamine, Frangrance (Parfum)
Package Label - Principal Display Panel
3785 mL NDC: 74391-003-01
237 mL NDC: 74391-003-08
* Please review the disclaimer below.
