Active Ingredient
Ethyl Alcohol 62% v/v. Purpose: Antibacterial
Hand Sanitizer
FDA Label NDC 80330-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Monarch Global Brands, Inc. for the product Hand Sanitizer (NDC 80330-001). 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, purpose, use[s], warnings, when using this product, stop use and consult doctor, 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
Antibacterial, Hand Sanitizer
Use[S]
- Hand Sanitizer to reduce bacteria on the skin
- Recommended for repeated use
Warnings
Flammable., keep away from fire and flame
For external use only
When Using This Product
do not use in or near the eyes. If contact occurs, rinse thoroughly with water.
Stop Use And Consult Doctor
if irritation occurs or rash appears and lasts.
Keep Out Of Reach Of Children.
If swallowed, get medical help or call a Poison Control Center.
Directions
- Place enough product in your palm to cover your hands
- Rub hands together briskly until dry
- Children under 6 years of age should be supervised when using this product
Other Information
- Store below 106F (41C)
- May discolor certain fabrics or surfaces
- Avoid freezing and heat above 105F (40C)
Inactive Ingredients
water, glycerin，triethanolamine,carbomer, Aloe Barbadensis Leaf extract, Tocopheryl Acetate
Questions Or Comments?
215 482 6100
Package Label - Principal Display Panel
237mL NDC: 80330-007-01
Papillon
HAND SANITIZER
WITH ALOE
62% ETHYL
ALCOHOL
CDC RECOMENDED
FORMULA
ETHYL ALCOHOL ANTISEPTIC
TOPICAL SOLUTION
8 oz. (237ml)
Pdp (80330 001 01)
355mL NDC: 80330-007-02
Papillon
HAND SANITIZER
WITH ALOE
62% ETHYL
ALCOHOL
CDC RECOMENDED
FORMULA
ETHYL ALCOHOL ANTISEPTIC
TOPICAL SOLUTION
12 oz. (355ml)
Pdp (80330 001 02)
3785mL NDC: 80330-007-03
Papillon
HAND SANITIZER
WITH ALOE
62% ETHYL
ALCOHOL
CDC RECOMENDED
FORMULA
ETHYL ALCOHOL ANTISEPTIC
TOPICAL SOLUTION
1 U.S. Gallon
Pdp (80330 001 03)
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