HAND SANITIZER- alcohol spray

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Scentsational Soaps & Candles, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 70% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

Hand Sanitizer to help reduce bacteria that potentially can cause a disease. For use when soap and water is not available.

WARNINGS

For extrenal use only. Flammable. Keep away from heat or flame.

DO NOT USE

* In children in less than 2 months of age

* on open skin wounds

WHEN USING

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritationor 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.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

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

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

STORAGE AND HANDLING

* Store between 15-30C (59-86F)

* Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

purified water USP, glycerin, Aloe barbadensis Leaf Juice, Hydrogen Peroxide

PRINCIPAL DISPLAY PANEL

100.55 mL NDC: 75078-002-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75078-002
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)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	27.425 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75078-002-01	100.55 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/11/2020

Labeler - Scentsational Soaps & Candles, Inc. (360738236)

Establishment
Name	Address	ID/FEI	Business Operations
Scentsational Soaps & Candles, Inc.		360738236	manufacture(75078-002)