OTC Medication Information: Ivgel Non-Sterile Solution Hydroxyethl

IVGEL NON-STERILE SOLUTION HYDROXYETHL- alcohol gel
VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V.

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.

Warning:

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

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

Other information:

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

Inactive Ingredients:

Water, Hydroxyethyl Cellulose, Triethanolamine.

Package Lableing

Lable
(click image for full-size original)

IVGEL NON-STERILE SOLUTION HYDROXYETHL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74967-001
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
HYDROXYETHYL CELLULOSE, UNSPECIFIED
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74967-001-01 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 04/30/2022
Labeler — VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V. (589993745)

Revised: 11/2021 VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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