Active Ingredient
Ethyl Alcohol 70% w/w. Purpose: Antiseptic
B Clean Hand Sanitizer
FDA Label NDC 78310-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heth Llc for the product B Clean Hand Sanitizer (NDC 78310-101). 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, do not use, otc - when using, otc - stop use, otc - 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, Hand Sanitizer
Use
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
- in children less than 2 months of age.
- on open skin wounds.
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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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
- 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 59°-86°F (15°-30°C)
- Avoid freezing and excessive heat above 104°F (40°C)
- May discolor certain fabrics
Inactive Ingredients
Aqua, Carbomer, Denatonium Benzoate, Isopropanolamine, Mentha Piperita Extract, Propylene Glycol, Salvia Officinalis Leaf Extract, Verbena Officinalis Leaf Extract
Package Label - Principal Display Panel
HAND SANITIZER
ALCOHOL-BASED GEL
moisturizing
Net wt. 15.52 oz (440g)
Manufactured by: Age do
Brasil Ind. e Com. LTDA.
Vinhedo SP
CEP 13288-169
Brazil
Distributed by: Heth LLC
7522 Campbell Road
Suite 113 #272
Dallas TX 75248
+1 844 989 3111
MADE IN BRAZIL
Warning! Flammable liquid and vapor
* Please review the disclaimer below.
