Otc - Active Ingredient
Active Ingredient
Ethanol 62%
Hand Sanitizer Liquid
FDA Label NDC 69674-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saraya Healthcare for the product Hand Sanitizer (NDC 69674-100). 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 - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Hand Sanitizer
Indications & Usage
Uses
- Sanitizes hands to help reduce bacteria that potentially can cause diseases
- Helps to prevent cross-contamination
- Helps to prevent drying of the skin
- Recommended for repeated use
Warnings
Warnings
- For external use only
- Flammable, keep away from fire or flame
Otc - When Using
When using this product
- Do not use in or near eyes
- Use in a well-ventilated area
- Discontinue use if irritation and redness develop
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
In case of accidental ingestion, seek medical attention or contact a poison control center immediately
Dosage & Administration
Directions
- Receive a small amount of foam into palm of hand
- Rub thoroughly over all surfaces of both hands, especially fingernails and cuticles
- Rub hands together until dry
Storage And Handling
Other information
- Store in a cool, dry place below 104°F
Inactive Ingredient
Inactive ingredients
Water, DEA-C8-18 perfluoroalkylethyl phosphate, glycereth-2 cocoate, denatonium benzoate, tert-butyl alcohol
Otc - Questions
Questions?
Contact Saraya Healthcare USA Mon - Fri
9am - 4pm PST at 866.822.1801
Other
Distributed by:
Saraya Healthcare USA
P.O. Box 1360
Penn Valley, CA 95946
866.822.1801
sarayahealthcareusa.com
Saraya Healthcare Usa
- Kills 99.999% of 26 tested pathogens in 15 seconds
- Formulated with emollients to help keep hands soft
- 62% Ethanol formula
Hand Sanitizer Foam
Net Contents: 1250mL (42 fl oz)
* Please review the disclaimer below.
