VUNNEX Hand Sanitizer: Package Insert and Label Information

VUNNEX HAND SANITIZER- alcohol liquid
VUNNEX INTERNATIONAL 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.

Active Ingredient

Alcohol 80% v/v

Purpose

Antiseptic.

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 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.

Uses

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

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

Inactive ingredients

GLYCERIN,HYDROGEN PEROXIDE,WATER

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VUNNEX HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79450-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
HYDROGEN PEROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79450-001-01 3 BOTTLE, SPRAY in 1 PACKAGE contains a BOTTLE, SPRAY
1 237 mL in 1 BOTTLE, SPRAY This package is contained within the PACKAGE (79450-001-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/15/2020
Labeler — VUNNEX INTERNATIONAL LLC (117547172)

Revised: 06/2020 VUNNEX INTERNATIONAL LLC

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