PURELL VF PLUS Hand Sanitizer Gel: Package Insert and Label Information

PURELL VF PLUS HAND SANITIZER GEL- alcohol gel
GOJO Industries, Inc.

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.

Active ingredient

Ethyl alcohol 85% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes 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 a Poison Control Center right away.

Directions

· Place enough product in your palm to thoroughly cover your hands

· Rub hands together briskly until dry

· Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Product Label

Product Label
(click image for full-size original)

PURELL VF PLUS HAND SANITIZER GEL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-837
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.85 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL ALCOHOL
CAPRYLYL GLYCOL
GLYCERIN
ISOPROPYL MYRISTATE
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
AMINOMETHYLPROPANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21749-837-02 60 mL in 1 PACKAGE None
2 NDC:21749-837-12 354 mL in 1 PACKAGE None
3 NDC:21749-837-40 1200 mL in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/01/2020
Labeler — GOJO Industries, Inc. (004162038)
Establishment
Name Address ID/FEI Operations
GOJO Industries, Inc. 036424534 manufacture (21749-837)

Revised: 01/2020 GOJO Industries, Inc.

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