Active Ingredient(S)
Isopropyl Alcohol 70% v/v
Sun Wave Consumer Antiseptic Hand Sanitizer
FDA Label NDC 75023-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sun Wave Wellness, Llc for the product Sun Wave Consumer Antiseptic Hand Sanitizer (NDC 75023-001). 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(s), warnings, otc - do not use, otc - when using, otc - stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use(S)
To help reduce bacteria on the skin. For use when soap and water are not available.
Warnings
For external use only.
Flammable. Keep away from heat or flame
Otc - Do Not Use
Do not use
- on children less than 2 months of age
- on open skin wounds
- around eyes
- in ears and mouth
Otc - When Using
When using this product keep out of eyes, ears, and mouth. 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 or rash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F).
Inactive Ingredients
Aloe Barbadensis (leaf) Extract, Fragrance, Glycerin, Purified Water
Package Label.Principal Display Panel
ANTISEPTIC
HAND
SANITIZER
SPRAY GEL
ALCOHOL ANTISEPTIC 70%
enriched with aloe
CLEAN SCENT
TOPICAL SOLUTION
KILLS
GERMS &
BACTERIA
3.4OZ 100ML
NO-STERILE SOLUTION
* Please review the disclaimer below.
