laevia Hand Sanitizer by Salvatori Industria e Comercio de Cosmeticos Ltda

laevia Hand Sanitizer by

Drug Labeling and Warnings

laevia Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Salvatori Industria e Comercio de Cosmeticos Ltda. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAEVIA HAND SANITIZER- alcohol gel 
Salvatori Industria e Comercio de Cosmeticos Ltda

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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This hand sanitizer is manufactured using the following ingredients:

1. Alcohol (ethanol) (70%, volume/volume (v/v)
2. Glycerol
3. Aminomethylpropanol
4. Carbomer Interpolymer Type A 55000 CPS
5. Denatonium Benzoate
6. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v.

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from fire or flame

Use

To decrease bacteria on the skin that could cause disease

recommended for repeated use.

Do not use

on children less than 2 months of age

When using this product

When using this product:

avoid contact with eyes, ears, and mouth. If contact occurs, flush thoroughly with water

avoid contact with broken skin

Stop use and ask a 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.

keep out of reach of pets

Directions

Apply a small portion on your hands, rub well and allow to dry without wiping

Use only as directed.

Other information

Store between 59-86°F

Avoid freezing and excessive heat above 104°F

May discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Glycerin, Aminomethylpropanol, Carbomer Interpolymer Type A (55000 CPS), Denatonium Benzoate

Package Label - Principal Display Panel

laevia Hand Sanitizer

500 mL NDC: 90052-101-01

Manufactured By:

Salvatori Ind. e Com. de Cosm. Ltda.

R. Nicolau Cacciatori, 320 - Presidente Prudente/SP

Made in Brazil

LAEVIA HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90052-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90052-101-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/29/2020	12/31/2021

Labeler - Salvatori Industria e Comercio de Cosmeticos Ltda (899682001)

Establishment
Name	Address	ID/FEI	Business Operations
Salvatori Industria e Comercio de Cosmeticos Ltda		899682001	manufacture(90052-101)

Revised: 4/2022

Document Id: db9f2b72-15d7-f006-e053-2a95a90ac9f6

34390-5

Set id: af737c91-38f0-56ae-e053-2995a90a005f

Version: 2

Effective Time: 20220401

 

Salvatori