Nutesse Hand Sanitizer Gel

Nutesse Hand Sanitizer Gel by

Drug Labeling and Warnings

Nutesse Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Industrias Bernal Canton S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NUTESSE HAND SANITIZER GEL- alcohol gel 
Industrias Bernal Canton 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.

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Nutesse Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

for hand washing to decrease bacteria on the skin.

Warnings

For external use only.
Flammable, keep away from fire and flame.

Do not use

in the eyes.

Stop use and ask a doctor if

irritation and redness develop.
condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

carbomer, glycerin, triethanolamine, polysorbate 20, EDTA, water.

Package Labeling:60ml

Package Labeling:250ml

Package Labeling:500ml

NUTESSE HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78239-001
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETIC ACID (UNII: 9G34HU7RV0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78239-001-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2020	04/01/2023
2	NDC: 78239-001-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2020	04/01/2023
3	NDC: 78239-001-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2020	04/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/30/2020	04/01/2023

Labeler - Industrias Bernal Canton S.A. de C.V. (812827340)

Revised: 3/2023

Document Id: f76d6c3e-2419-ded4-e053-6294a90af58c

34390-5

Set id: b3fce62c-d515-e31a-e053-2a95a90a1b99

Version: 2

Effective Time: 20230321