Active Ingredient
Ethyl Alcohol 75%
Oustane Hand Sanitizer
FDA Label NDC 79128-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cadence Keen Innovations, Inc. for the product Oustane Hand Sanitizer (NDC 79128-000). 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, uses, warnings, when using this product, stop using and ask a doctor if, 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
Uses
Hand washing to reduce bacteria on skin, suitable when water is unavailable
Warnings
External Use only
Flammable, keep away from fire or flame
When Using This Product
Avoid contact with eyes, rinse thoroughly with water if contact occurs
Stop Using And Ask A Doctor If
Skin irritation or redness develop or increase
Keep Out Of Reach Of Children
If swallowed, get medical attention or contact a Poison Control Center right away.
Directions
- Pour suitable enough product in your palm and rub together until dry.
- Children under 8 years of age should be used under supervision.
Inactive Ingredients
Water, Parfum(fragance), Propanediol, Polysorbate 20, Glycerin
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Package Labeling: 50Ml
Bottle (Bottle)
Package Labeling: 500Ml
Bottle2 (Bottle2)
Package Labeling:3.785L
Bottle3 (Bottle3)
* Please review the disclaimer below.
