SAVIE Blue Light Hand Sanitizer

SAVIE Hand Sanitizer by

Drug Labeling and Warnings

SAVIE Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by AVB COMERCIO IMPORTACAO E DISTRIBUICAO EIRELI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SAVIE HAND SANITIZER- alcohol gel 
AVB COMERCIO IMPORTACAO E DISTRIBUICAO EIRELI

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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SAVIE Blue Light Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand Sanitizer to help decrease bacteria and germs on the skin.

Warnings:

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

Avoid contact with eyes,

in case of contact, rinse eyes thoroughly with water immediately.

Stop use and ask a doctor

if irritation or readness devolops.

Keep out of reach of children.

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

DO NOT SWALLON,

containes denaturing. The product contains DENATONIUM BENZOATE as a denaturant.

Directions

Topical use. Apply the gel on the skin, spreading it gently through circular movements, until complete absorption.

Other Information.

Store below 110°F (43°C). May discolor fabrics or surfaces. Keep the product in its original packaging.

Inactive Ingredients

Aqua (water), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Glycerin, Isopropanolamine, and Denatonium Benzoate.

​Questions or Comments: +1 508 401-7163

Package 60ml

Package 100ml

Package 250ml

Package 500ml

SAVIE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78699-000
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)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
ISOPROPANOLAMINE (UNII: UE40BY1BZW)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78699-000-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/29/2020	10/31/2022
2	NDC: 78699-000-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/29/2020	12/31/2020
3	NDC: 78699-000-03	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/29/2020	12/31/2020
4	NDC: 78699-000-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/29/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/29/2020	10/31/2022

Labeler - AVB COMERCIO IMPORTACAO E DISTRIBUICAO EIRELI (944841505)

Revised: 8/2021

Document Id: cad1fa81-cf7d-6728-e053-2a95a90ab3f9

34390-5

Set id: adf9b685-1d64-5ae5-e053-2995a90a6db3

Version: 3

Effective Time: 20210830

 

AVB C