Hand Sanitizer by Ecodeli Comercial SA de CV Dado de baja

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ecodeli Comercial SA de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- ethyl alcohol gel 
Ecodeli Comercial 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.

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Dado de baja

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Superviser children under 6 years of age when using this product to avoid swallowing.

Warnings

For external use only. Flammable. Keep away from heat of flame.

Inactive Ingredients

Water, propylene glycol, glycerin, polyacrylic acid, triethanolamine.

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

Purpose

Antiseptic, hand sanitizer

Active Ingredient(s)

Ethyl alcohol 75 % v/v

Do not use

In children less than 2 months of age

On open skin wounds

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

If irritation or rash occurs. These may be signs of a serious condition.

Store between 15-30 °C (59-86 °F)

Avoid freezing and excesive heat above 40 °C (104 °F)

250 mL NDC: 76880-002-01

1000 mL NDC: 76880-002-02

3780 mL NDC: 76880-002-03

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76880-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	20.2 mL  in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76880-002-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2020	12/14/2020
2	NDC: 76880-002-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2020	12/14/2020
3	NDC: 76880-002-03	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2020	12/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/04/2020	12/14/2020

Labeler - Ecodeli Comercial SA de CV (588530951)

Registrant - Ecodeli Comercial SA de CV (588530951)

Establishment
Name	Address	ID/FEI	Business Operations
Ecodeli Comercial SA de CV		588530951	manufacture(76880-002)

Revised: 1/2021

Document Id: b9fb0c91-7c15-4c67-e053-2a95a90a6c14

34390-5

Set id: a745bf44-327e-1f4f-e053-2a95a90aaeca

Version: 4

Effective Time: 20210128