Label: BACTERIA ZERO PREMIUM- peracetic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80138-201-01, 80138-201-02, 80138-201-03 - Packager: KUMSUNG ENC CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated August 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
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- Package Label
-
INGREDIENTS AND APPEARANCE
BACTERIA ZERO PREMIUM
peracetic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80138-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERACETIC ACID (UNII: I6KPI2E1HD) (PERACETIC ACID - UNII:I6KPI2E1HD) PERACETIC ACID 0.01 g in 100 mL Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) HYDROGEN PEROXIDE (UNII: BBX060AN9V) PHOSPHOROUS ACID (UNII: 35V6A8JW8E) WATER (UNII: 059QF0KO0R) 99.939 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80138-201-01 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/24/2020 2 NDC:80138-201-02 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/24/2020 3 NDC:80138-201-03 500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/24/2020 Labeler - KUMSUNG ENC CO., LTD (688082226) Registrant - KUMSUNG ENC CO., LTD (688082226) Establishment Name Address ID/FEI Business Operations KUMSUNG ENC CO., LTD 688082226 manufacture(80138-201)