Label: BACTERIA BLASTER- alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 76653-080-01 - Packager: Port Royal Distillers Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
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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
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BACTERIA BLASTER
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76653-080 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76653-080-01 3780 mL in 1 CONTAINER; Type 0: Not a Combination Product 04/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/24/2020 Labeler - Port Royal Distillers Inc. (202611745) Registrant - Port Royal Distillers Inc. (202611745) Establishment Name Address ID/FEI Business Operations Port Royal Distillers Inc. 202611745 manufacture(76653-080)