VILLA FLORIANI INSTANT HAND SANITIZER: Package Insert and Label Information

VILLA FLORIANI INSTANT HAND SANITIZER- alcohol gel
ORIGINITALIA SRL

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.

Drug Facts

Active ingredients

Alcohol 70% v/v

Purpose

Antiseptic

Uses

  • Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable; Keep away from fire or flame.

For external use only

Do not use

  • on children less than 2 months of age
  • on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, 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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

Aqua (Water), Isopropyl Alcohol, Carbomer, Glycerin, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

Company Information

Originitalia srl

36030 Caldogno (VI)

Made in Italy

www.villafloriani.com

Product Packaging — 500 ml bottle

VILLA FLORIANI

INSTANT

HAND SANITIZER

TEA TREE OIL, ALOE VERA

CONTAINS 70% ALCOHOL

TOUGH ON GERMS, GENTLE ON HANDS

An instant, fast-absorbing hand sanitizer

made with plant-based alcohol to wash

hands, rinse-free. Practical for when

on-the-move and in situations where

soap and water are not readily available

(public transport, traveling, etc.).

Infused with Tea Tree Oil and Aloe Vera to

help soften and moisturize the skin.

www.villafloriani.com

500 ml 17 fl.oz. MADE IN ITALY

hand sanitizer
(click image for full-size original)
VILLA FLORIANI INSTANT HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68586-291
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL ALCOHOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ALOE VERA LEAF
TEA TREE OIL
GLYCERIN
AMINOMETHYLPROPANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68586-291-02 500 mL in 1 BOTTLE None
2 NDC:68586-291-01 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/01/2020
Labeler — ORIGINITALIA SRL (441072253)

Revised: 03/2020 ORIGINITALIA SRL

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