ANTISEPTIC HAND SANITIZER- alcohol spray

Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by MiracleCorp Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

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

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wound

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

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

Directions

• 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.

Other Information

• Store between 15-30C (59-86F)

Inactive Ingredients

Hydrogen Peroxide, Glycerol, Distilled Water

PRINCIPAL DISPLAY PANEL - 103.5 ml Bottle Label

Alcohol Antiseptic 80%
Topical Solution

Antiseptic
Hand Sanitizer
Non-Sterile Solution

Made in Dayton, Ohio by Your Friends at

Buckeye™
VODKA

buckeyevodka.com

MiracleCorp
Premium Pet Products
miraclecorp.com

3.5 fl oz | 103.5 ml

DO NOT STORE ABOVE 86F
SAMPLE - NOT FOR SALE
NOT FOR CONSUMPTION

238910_041320

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61429-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Hydrogen Peroxide (UNII: BBX060AN9V)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61429-005-20	103.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/20/2020
2	NDC: 61429-005-30	473.18 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	04/20/2020

Labeler - MiracleCorp Products (604479543)

Establishment
Name	Address	ID/FEI	Business Operations
MiracleCorp Products		604479543	MANUFACTURE(61429-005)