Sanitell INSTANT HAND SANITIZER

Sanitell INSTANT HAND SANITIZER by

Drug Labeling and Warnings

Sanitell INSTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Miramar Cosmetic, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITELL INSTANT HAND SANITIZER- isopropyl alcohol gel 
Miramar Cosmetic, Inc.

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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Sanitell INSTANT HAND SANITIZER

Drug Facts

Active Ingredient

Isopropyl Alcohol 70%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

-For external use only.

-Keep away from fire or flame.

When using this product do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if irritation and redness develop and persist.

Keep out of reach of children. If swallowed, get medical help promptly.

Other Information

-Store below 110 F (43 C). May discolor certain fabrics or surfaces.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using.

Inactive ingredients: Purified water, Carbomer (polymer crosslinked), Glycerin, Tocopheryl Acetate (Vitamin E), Triethanolamine, Fragrance.

Vita Mex USA

Antibacterial 

kills 99.9% of germs

Distributed by:

Vita Mex USA

www.vitamexusa.com

QUALITY ASSURED

cGMP

MADE IN USA

SATISFACTION GAURANTEED QUALITY

Packaging

SANITELL INSTANT HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79974-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79974-200-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2020	09/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/04/2020	09/30/2023

Labeler - Miramar Cosmetic, Inc. (012873243)

Establishment
Name	Address	ID/FEI	Business Operations
Miramar Cosmetic, Inc.		012873243	manufacture(79974-200)

Revised: 8/2022

Document Id: 8086a583-0b98-4b2d-908f-1b4143bf5c7c

34390-5

Set id: b584a43c-a009-48d1-8e19-37d0f1ceaff1

Version: 2

Effective Time: 20220823