BACTERIA ZERO PREMIUM- peracetic acid liquid 
KUMSUNG ENC CO., LTD

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.

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80138-201

Active ingredient

Peracetic acid 0.01%

Purpose

Antiseptic

USE

Fruits, Vegetables, Meat Sterilization(Food Additives), General Object surface Sterilization Sanitizer to help reduce bacteria that potentially can disease.

WARNINGS

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

Check the indications before use.

Do not inhale the contents that are sprayed or sprayed directly on a person.

When using this product

keep away from 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.

DIRECTIONS

- If the original solution is sprayed on a contaminated place, wipe it with a dry cloth or if it is naturally dried, harmful bacteria are immediately sterilized.

- Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

- Store between 1~30℃(33.8~86℉)

- Avoid freezing(-5℃) and excessive heat above 35℃(86℉)

INACTIVE INGREDIENTS

acetic acid, hydrogen peroxide, Phosphonic acid, purified water USP

Package Label

60ml NDC: 80138-201-01 Label

100ml NDC: 80138-201-02 Label

500ml NDC: 80138-201-03 Label

BACTERIA ZERO PREMIUM 
peracetic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80138-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PERACETIC ACID (UNII: I6KPI2E1HD) (PERACETIC ACID - UNII:I6KPI2E1HD) PERACETIC ACID0.01 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID (UNII: Q40Q9N063P)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
PHOSPHOROUS ACID (UNII: 35V6A8JW8E)  
WATER (UNII: 059QF0KO0R) 99.939 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80138-201-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2020
2NDC:80138-201-02100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2020
3NDC:80138-201-03500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2020
Labeler - KUMSUNG ENC CO., LTD (688082226)
Registrant - KUMSUNG ENC CO., LTD (688082226)
Establishment
NameAddressID/FEIBusiness Operations
KUMSUNG ENC CO., LTD688082226manufacture(80138-201)

Revised: 8/2020
Document Id: ad980a16-1db7-40da-e053-2a95a90a12be
Set id: ad980a16-1db6-40da-e053-2a95a90a12be
Version: 1
Effective Time: 20200823
 
KUMSUNG ENC CO., LTD