Happy Hands Hand Sanitizer
FDA Label NDC 78705-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by South Tenth Development, Llc for the product Happy Hands Hand Sanitizer (NDC 78705-001). 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 drug facts, active ingredient, purpose, use[s], warnings, do not use, when using this product, stop use & ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl Alcohol 80%
Purpose
Antiseptic
Use[S]
Health care personnel hand rub to help reduce bacteria that potentially can cause disease.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- on open skin wounds
- in children less than 2 months of age
When Using This Product
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use & Ask A Doctor
if irritation or rash occurs. These may be signs of a serious condition.
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
Distilled water, glycerol, hydrogen peroxide, denatonium benzoate.
Package Labeling: 100Ml
Bottle (Bottle)
Package Labeling: 300Ml
Label2 (Label2)
Package Labeling: 500 Ml
Label3 (Label3)
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