DISPOSABLE DISINFECTANT- disposable spray disinfectant spray

Disposable Disinfectant by

Drug Labeling and Warnings

Disposable Disinfectant by is a Otc medication manufactured, distributed, or labeled by Hunan Cihui Medical Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DO NOT USE

WHEN USING

STOP USE

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

DISPOSABLE DISINFECTANT 
disposable spray disinfectant spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74762-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF)	POLIHEXANIDE	0.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74762-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020
2	NDC: 74762-001-02	70 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020
3	NDC: 74762-001-03	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020
4	NDC: 74762-001-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020
5	NDC: 74762-001-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/15/2020

Labeler - Hunan Cihui Medical Technology Co., Ltd. (404377938)

Registrant - Hunan Cihui Medical Technology Co., Ltd. (404377938)

Establishment
Name	Address	ID/FEI	Business Operations
Hunan Cihui Medical Technology Co., Ltd.		404377938	manufacture(74762-001)