ANTISEPTIC HAND SANITIZER- alcohol spray 
MiracleCorp Products

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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Antiseptic Hand Sanitizer

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

Other Information

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

Principal Display Panel - 103.5 ml Bottle Label
ANTISEPTIC HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61429-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Hydrogen Peroxide (UNII: BBX060AN9V)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61429-005-20103.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/2020
2NDC:61429-005-30473.18 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E04/20/2020
Labeler - MiracleCorp Products (604479543)
Establishment
NameAddressID/FEIBusiness Operations
MiracleCorp Products604479543MANUFACTURE(61429-005)

Revised: 4/2020
Document Id: 1cc9b8e0-7722-493a-b48e-a9bab0aa2642
Set id: fd83de9f-15e5-464e-ae58-9a5d79d1ac0e
Version: 1
Effective Time: 20200427
 
MiracleCorp Products