SAVIE Hand Sanitizer by AVB COMERCIO IMPORTACAO E DISTRIBUICAO EIRELI SAVIE 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 Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria and germs on the skin

Directions

Topical Use. Apply the gel directly to the skin, spreading it gently through circular movements, until complete absorption.

Keep out of reach of children

in case of accidental ingestion, get medical help or contact a Poison Control Center or Health Services immediately.

Inactive Ingredients

Aqua(Water), Vegetable Glycerin, Carbomer, Triethanolamine, Parfum, Benzyl Salicylate, Linalool, Limonene, Hidroxycitronellal, Coumarin, Tocopheryl Acetate, Aloe Babarbadensis Leaf Juice, Cinnamomun Camphora Leaf oil.

Warnings:

Flammable Product. Keep away from source of heat, fire or flame. Do not drill the cover of packing.

Avoid direct contact with eyes and mucous membranes.

If contact occurs. Rinse with water. Do not ingest the product. Flammable product can cause burns.

DO NOT SWALLON

containes denaturant. The product contains VEGETABLE GLYCERINE as a denaturant.

Other Information.

Store at a temperature below 110°F (43%). / May discolor certain fabrics of surfaces. Keep the product in its original packing.

​Questions or Comments: 1 508 401 7163

Package Labeling 1 L

Package Labeling 5 L

Package labeling 200 L

SAVIE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78699-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
COUMARIN (UNII: A4VZ22K1WT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR LEAF OIL (UNII: 51D0RGY52V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78699-002-01	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2020	12/30/2020
2	NDC: 78699-002-02	5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2020	12/30/2020
3	NDC: 78699-002-03	200 L in 1 DRUM; Type 0: Not a Combination Product	07/09/2020	12/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/09/2020	12/30/2020

Labeler - AVB COMERCIO IMPORTACAO E DISTRIBUICAO EIRELI (944841505)

Revised: 8/2021

Document Id: cad20d81-c23b-95c1-e053-2a95a90ae958

34390-5

Set id: aa17057f-c23c-04a3-e053-2a95a90adf43

Version: 2

Effective Time: 20210830

 

AVB C