PF HAND SANITIZING

Dosage form: spray
Ingredients: ALCOHOL 70mL in 100mL
Labeler: Premium Formulations LLC
NDC Code: 76323-005

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

HAND SANITIZING SPRAY

Active Ingredients                               

Ethyl Alcohol 70 percent

Purpose
Antiseptic

Uses

Hand sanitizing to help reduce bacteria on the skin that could cause disease.

Directions

  • Spray enough product in your palm to thoroughly cover and wet your hands.
  • Rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product

Warnings

Flammable, Keep away from fire or 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 ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children.  If swallowed, get medical help or contact Poison Control Center right away.

Other information

Do not store above 110 degree Fahrenheit (43 degree Celsius).

May discolor certain fabrics or surfaces.

Water(Aqua), Glycerin, Tocopheryl Acetate, Fragrance(Parfum).

Distributed by:

Premium Formulations LLC

220E, Delaware Ave Newark,

DE - 19711

Manufactured in China

KILLS 99.9 percent OF GERMS

PF

Premium Formulations

Anti-Bacterial Hand Sanitizing Spray

Over 150 Sprays!

0.5 FL OZ (15 ml)

PF HAND SANITIZING 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76323-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:76323-005-0015 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E07/01/2011
Labeler - Premium Formulations LLC (831281097)
Registrant - American Hygienics Corporation (545198454)
Establishment
NameAddressID/FEIOperations
American Hygienics Corporation545198454manufacture

Revised: 10/2011
 
Premium Formulations LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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