DISPOSABLE DISINFECTANT- disposable spray disinfectant spray 
Hunan Cihui Medical Technology 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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Disposable Spray Disinfectant

Active Ingredients

Polyhexamethylene biguanidine(0.4%).

Purpose

Antimicrobial disinfectant

Uses

Warnings

Store in a cool, dry,well-ventilated and clean room with relative humidity not exceeding

80% and no corrosive gases.

Directions

1,Total skin disinfection:apply directly to skin,either by spraying or wiping, for 1 minute

2,Mucous membrane disinfection(not suitable for use on vaginal mucosa) ;

2.1,Rinse oral cavity using the undiluted solution for 1 minute.Rinse mouth out with water after disinfecting.

2.2,Apply directly to the membrane and rub into the surface for one minute.

3, Hand sanitizing:Apply directly to hands,either by spraying or wiping, and rub in for 1 minute.

4,Hand sanitizing for surgical purposes:Apply directly to hands, either by spraying, wiping, or soaking in the undiluted solution, for 3 minutes.

5,Disinfecting the surfaces of objects:Apply directly to the surface, either by spraying or wiping, for 10 minutes.

Other information

1, If there is any precipitation observed as a result of the storage process, this is a normal phenomenon and does not affect the product's efficacy.

2, For external use only,oral administration is strictly prohibited.

3,Please keep the product out of reach of children.

4, When used for mucous membrane disinfection,this should be limited to diagnosis and treatment inside medical institutions.

5, Do not use if any allergies against polyhexamethylene biguanidene are known, people with allergies should use with caution.

6,This product cannot be used together with soap or other anionic detergents.

7, This product has a moderately corrosive effect on carbon steel, but is suitable for the disinfection of copper,

stainless steel,aluminum, and ceramic surfaces.

INACTIVE INGREDIENTS

Water,citric acid,aromatics,alcohol.

Package Label - Principal Display Panel

512

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DISPOSABLE DISINFECTANT 
disposable spray disinfectant spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74762-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE0.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74762-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
2NDC:74762-001-0270 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
3NDC:74762-001-03200 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
4NDC:74762-001-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
5NDC:74762-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2020
Labeler - Hunan Cihui Medical Technology Co., Ltd. (404377938)
Registrant - Hunan Cihui Medical Technology Co., Ltd. (404377938)
Establishment
NameAddressID/FEIBusiness Operations
Hunan Cihui Medical Technology Co., Ltd.404377938manufacture(74762-001)

Revised: 4/2020
Document Id: a34c2504-3cb6-c93a-e053-2a95a90a760e
Set id: a34c4936-3441-3c91-e053-2995a90a640b
Version: 1
Effective Time: 20200414
 
Hunan Cihui Medical Technology Co., Ltd.