Verasteril Advanced Hand Sanitizer: Package Insert and Label Information

VERASTERIL ADVANCED HAND SANITIZER- isopropyl alcohol gel
Euroclydon Laboratories USA LLC

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 ingredient(s)

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Use(s)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

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 occurs. These may be signs of a serious condition.

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 15-30c (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Purified Water, Glycerin, Carbomer, Aminomethyl Propanol, Triethanolamine, Hydrogen Peroxide

Package Labeling:127.8oz

Label
(click image for full-size original)

Package Labeling:16.9oz

Label2
(click image for full-size original)

Package Labeling:2oz

Label3
(click image for full-size original)

VERASTERIL ADVANCED HAND SANITIZER
isopropyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79236-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.75 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
AMINOMETHYLPROPANOL
TROLAMINE
HYDROGEN PEROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79236-000-01 3780 mL in 1 BOTTLE None
2 NDC:79236-000-02 500 mL in 1 BOTTLE None
3 NDC:79236-000-03 60 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/28/2020
Labeler — Euroclydon Laboratories USA LLC (117515845)

Revised: 06/2020 Euroclydon Laboratories USA LLC

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