BACTERIA BLASTER- alcohol solution 
Port Royal Distillers 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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Active Ingredient

Alcohol 80% v/v.

Purpose

Antiseptic

Use

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

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 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.

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

glycerin, hydrogen peroxide, purified water USP

Principal Display Panel

NDC 76653-080-01

HAND AND SURFACE SANITIZER

REFILL

BACTERIA BLASTER

80% ALCOHOL

WORLD HEALTH ORGANIZATION APPROVED FORMULA

Fragrance Free

Alcohol Antiseptic 80% Topical Solution

Non-sterile Solution

3780 mL

1 US Gal.

Front

Back

BACTERIA BLASTER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76653-080
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
GLYCERIN (UNII: PDC6A3C0OX) 1.45 L  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L  in 100 mL
WATER (UNII: 059QF0KO0R) 18.425 L  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76653-080-013780 mL in 1 CONTAINER; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2020
Labeler - Port Royal Distillers Inc. (202611745)
Registrant - Port Royal Distillers Inc. (202611745)
Establishment
NameAddressID/FEIBusiness Operations
Port Royal Distillers Inc.202611745manufacture(76653-080)

Revised: 4/2020
Document Id: 16debcff-af21-44a7-a84a-2ea1cf4669b5
Set id: 174c2df9-8cd1-4220-bda7-596f747c9b52
Version: 1
Effective Time: 20200423
 
Port Royal Distillers Inc.