AMORAY- ethyl alcohol aerosol, spray
KOZMO KIMYA SANAYI VE DIS TICARET LIMITED SIRKETI

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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AMORAY SANITIZER SPRAY 75 ml

Purpose

Sanitizer Spray

Active Ingredients..................Purpose

Ethyl Alcohol 70%.................................................................. Purpose: Antiseptic

Uses

Hand sanitizer to help reduce germs in the skin that can potentially cause diseases.
Recommended for repeated use.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Contents under pressure.

Do not puncture or incinerate.

Do not store at temperatures above 120°F(48°C).

When using this product

Keep our of eyes. In case of eye contact, flush eyes with water.
Avoid contact with broken skin.

Stop use and ask a doctor

Stop use and ask a doctor if irritation or redness develops, or if condition persist for more than 72 hours.

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.

Directions

Wet hands thoroughly with product.
Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles.
Allow to dry without wiping.

Inactive Ingredients

Water, Butane, Isobutane, Propane, Glycerin, PEG-40 Hydrogenated Castor Oil, Panthenol, Aloe Barbadensis Leaf Juice (Aloe Vera), Tocopheryl Acetate (Vitamin E)

Questions or comments?

Questions or comments? 1-877-879-6999

Package Label

75 ML, NDC:75822-027-03

label

AMORAY
ethyl alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75822-027
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.1 mL in 100 mL
ISOBUTANE (UNII: BXR49TP611)	5 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL in 100 mL
BUTANE (UNII: 6LV4FOR43R)	9.1 mL in 100 mL
PROPANE (UNII: T75W9911L6)	5.1 mL in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.1 mL in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1 mL in 100 mL
WATER (UNII: 059QF0KO0R)	10.1 mL in 100 mL
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)	0.3 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75822-027-03	75 mL in 1 CAN; Type 0: Not a Combination Product	04/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/26/2020

Labeler - KOZMO KIMYA SANAYI VE DIS TICARET LIMITED SIRKETI (535362693)

Revised: 1/2021

Document Id: b89d3d0e-6c22-3c50-e053-2a95a90a2f3c

Set id: a41ebec3-85a4-4fb0-e053-2a95a90a1c4c

Version: 7

Effective Time: 20210105

KOZMO KIMYA SANAYI VE DIS TICARET LIMITED SIRKETI