IVGEL Hand Sanitizer: Package Insert and Label Information

IVGEL HAND SANITIZER- alcohol gel
Vago International Manufacturing SA de CV

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.

IVGEL Drug Fact Chart

Active ingredients:

Ethyl Alcohol at 70%

Purpose

Antiseptic

Uses:

Hand Sanitizer to help reduce germs. For use when soap and water not available.

Warnings:

For external use only, Flammable. Keep away from open flame and sources of heat or flame.

Do not use:

In children lass 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 of serious condition

Stop use and ask doctor:

If a 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:

Apply a small amount of product into hands and rub between both side of hands until dry. Supervise children under 6 years of age when
using this product to avoid swallowing.

Other information:

Store below 110 o F (43 o C). Avoid freezing. May discolor certain fabrics or surface.

Inactive Ingredients:

Water, Glycerin, Carbopol, Trithanolamine

Package Labeling:

1
(click image for full-size original)

IVGEL HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74967-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74967-000-01 1000 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 04/15/2020
Labeler — Vago International Manufacturing SA de CV (589993745)

Revised: 05/2020 Vago International Manufacturing SA de CV

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