BIOPURE ANTIBACTERIAL HAND WIPE 0.12% BENZALKONIM CHLORIDE (250 CT)- antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE (1400 CT)- antibacterial hand wipe cloth 75% ALCOHOL WET WIPES- alcohol wet wipes cloth BIOPURE ANTIBACTERIAL HAND WIPE BENZALKONIUM CHLORIDE 0.12% (250 CT)- antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE- biopure antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE UNSCENTED (1400 CT)- biopure antibacterial hand wipe unscented cloth Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Ethyl Alcohol 75%………………Antisepetic Purified Water USP For external use only. Flammable. Keep away from heat or flame. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use in children less than 2 months of age. Do not use on open wounds. Apply to hands, allow to air dry without wipping. Discard wipe in trash receptable after use. Do not flush. To help reduce bacteria that potentially cause disease. To help reduce bacteria that potentially cause disease
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BIOPURE ANTIBACTERIAL HAND WIPE 0.12% BENZALKONIM CHLORIDE (250CT)- antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE (1400 CT)- antibacterial handwipe cloth 75% ALCOHOL WET WIPES- alcohol wet wipes cloth BIOPURE ANTIBACTERIAL HAND WIPE BENZALKONIUM CHLORIDE 0.12% (250CT)- antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE- biopure antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE UNSCENTED (1400 CT)- biopureantibacterial hand wipe unscented cloth Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with applicable regulations and policies. FDA has notevaluated whether this product complies.
----------Ethyl Alcohol 75%………………AntisepeticPurified Water USPFor external use only. Flammable. Keep away from heat or flame.Keep out of reach of children. If swallowed, get medical help or contact a Poison ControlCenter right away.Do not use in children less than 2 months of age.Do not use on open wounds.Apply to hands, allow to air dry without wipping.Discard wipe in trash receptable after use.Do not flush.To help reduce bacteria that potentially cause disease.To help reduce bacteria that potentially cause disease
BIOPURE ANTIBACTERIAL HAND WIPE 0.12% BENZALKONIMCHLORIDE (250 CT) antibacterial hand wipe cloth
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-500
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength StrengthBENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)
BENZALKONIUMCHLORIDE
12 in 100
Inactive IngredientsIngredient Name Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T)
Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:79794-500-
01250 in 1 CANISTER; Type 0: Not a CombinationProduct 10/20/2020
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part333A 10/20/2020
BIOPURE ANTIBACTERIAL HAND WIPE (1400 CT) antibacterial hand wipe cloth
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-300
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)
BENZALKONIUMCHLORIDE
12 in 100
Inactive IngredientsIngredient Name Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:79794-300-
011400 in 1 PACKAGE; Type 0: Not a CombinationProduct 07/23/2020
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part333A 07/23/2020
75% ALCOHOL WET WIPES alcohol wet wipes cloth
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-100
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 in 100
Inactive IngredientsIngredient Name Strength
WATER (UNII: 059QF0KO0R)
Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:79794-100-
01100 in 1 CANISTER; Type 0: Not a CombinationProduct 07/23/2020
2 NDC:79794-100-03
120 in 1 CANISTER; Type 0: Not a CombinationProduct 07/23/2020
3 NDC:79794-100-02
80 in 1 PACKAGE; Type 0: Not a CombinationProduct 07/23/2020
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part333A 07/23/2020
BIOPURE ANTIBACTERIAL HAND WIPE BENZALKONIUM CHLORIDE0.12% (250 CT) antibacterial hand wipe cloth
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-200
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)
BENZALKONIUMCHLORIDE
12 in 100
Inactive IngredientsIngredient Name Strength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T)
Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:79794-200-
01250 in 1 PACKAGE; Type 0: Not a CombinationProduct 07/23/2020
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part333A 07/23/2020
BIOPURE ANTIBACTERIAL HAND WIPE biopure antibacterial hand wipe cloth
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-400
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)
BENZALKONIUMCHLORIDE
0.13 in 100
Inactive IngredientsIngredient Name Strength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) ALOE (UNII: V5VD430YW9)
Product CharacteristicsColor white Score
Color ScoreShape SizeFlavor Imprint CodeContains
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:79794-400-
0140 in 1 POUCH; Type 0: Not a CombinationProduct 09/14/2020
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part333A 09/14/2020
BIOPURE ANTIBACTERIAL HAND WIPE UNSCENTED (1400 CT) biopure antibacterial hand wipe unscented cloth
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-600
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)
BENZALKONIUMCHLORIDE
12 in 100
Inactive IngredientsIngredient Name Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R)
Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:79794-600-
011400 in 1 PACKAGE; Type 0: Not a CombinationProduct 10/20/2020
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part333A 10/20/2020
Labeler - Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. (723796509)
EstablishmentName Address ID/FEI Business Operations
Zhejiang Furuisen SpunlacedNonwovens Co.,Ltd. 723796509 manufacture(79794-100, 79794-200, 79794-300, 79794-
400, 79794-500, 79794-600)
Revised: 10/2021
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