IVGEL Hand Sanitizer: Package Insert and Label Information

IVGEL HAND SANITIZER- 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.

Drug Fact

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 110oF (43oC). Avoid freezing. May discolor certain fabrics or surfaces

Inactive Ingredients:

Water, Glycerine, Carbopol, Triethanolamine.

Package Labeling

Label
(click image for full-size original)

IVGEL HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74967-003
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:74967-003-00 250 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 05/27/2020 04/30/2022
Labeler — VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V. (589993745)

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

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