Label: DISPOSABLE DISINFECTANT- disposable spray disinfectant spray
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Contains inactivated NDC Code(s)
NDC Code(s): 74762-001-01, 74762-001-02, 74762-001-03, 74762-001-04, view more74762-001-05 - Packager: Hunan Cihui Medical Technology 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 April 14, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
DISPOSABLE DISINFECTANT
disposable spray disinfectant sprayProduct 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)
