Ivresse Hand Sanitizer by Ivresse Internacional, S.A. de C.V. Ivresse Hand Sanitizer

Ivresse Hand Sanitizer by

Drug Labeling and Warnings

Ivresse Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ivresse Internacional, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IVRESSE HAND SANITIZER- alcohol gel 
Ivresse Internacional, 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.

----------

Ivresse Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin when water, soap & towel are not available.
• Recommended for repeat use.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When use this product:

• Keep out of eyes. In case of contact with eyes, rinse thoroughly with water.
• Do not use on broken or irritated skin.

Stop use and ask a doctor

If irritation or redness develop and last more than 72 hours.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other Information

• Do not store above 105 F (40 C).
• May discolor certain fabrics and wood surfaces.

Inactive Ingredients:

water, carbomer, triethanolamine, glycerin, propylene glycol, aloe barbadensis leaf juice.

Package Labeling: 40ml

Package Labeling: 250ml

Package 30 ML

IVRESSE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78740-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78740-002-01	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020	03/01/2022
2	NDC: 78740-002-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020	03/01/2022
3	NDC: 78740-002-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/18/2020	03/01/2022

Labeler - Ivresse Internacional, S.A. de C.V. (814233193)

Revised: 9/2023

Document Id: 053eba2d-edfe-c48c-e063-6294a90a2345

34390-5

Set id: a8c5dab5-43d3-e25f-e053-2a95a90a63ed

Version: 4

Effective Time: 20230913