Label: INSTANTFOAM NON-ALCOHOL HAND SANITIZER- benzalkonium chloride liquid
SAFE-T-FRESH ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid
DRUMMOND AERO INSTANT- benzalkonium chloride liquid
UNITED LABS INSTANT FOAM- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11084-057-01, 11084-057-05, 11084-057-20, 11084-057-27, view more11084-057-40, 11084-112-01, 11084-112-27, 11084-113-27, 11084-113-40, 11084-129-27 - Packager: Deb USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 27, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INSTANTFOAM NON-ALCOHOL HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-057 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) EDETATE SODIUM (UNII: MP1J8420LU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) MAGNESIUM NITRATE (UNII: 77CBG3UN78) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11084-057-01 47 mL in 1 BOTTLE, PUMP 2 NDC:11084-057-05 3780 mL in 1 BOTTLE, PLASTIC 3 NDC:11084-057-20 2000 mL in 1 BOTTLE, PLASTIC 4 NDC:11084-057-27 1000 mL in 1 BOTTLE, PLASTIC 5 NDC:11084-057-40 400 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2010 SAFE-T-FRESH ALCOHOL FREE HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) EDETATE SODIUM (UNII: MP1J8420LU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) MAGNESIUM NITRATE (UNII: 77CBG3UN78) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11084-129-27 1000 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2010 DRUMMOND AERO INSTANT
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) EDETATE SODIUM (UNII: MP1J8420LU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) MAGNESIUM NITRATE (UNII: 77CBG3UN78) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11084-112-01 47 mL in 1 BOTTLE, PUMP 2 NDC:11084-112-27 1000 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2010 UNITED LABS INSTANT FOAM
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) EDETATE SODIUM (UNII: MP1J8420LU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) MAGNESIUM NITRATE (UNII: 77CBG3UN78) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11084-113-27 400 mL in 1 BOTTLE, PUMP 2 NDC:11084-113-40 47 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2010 Labeler - Deb USA, Inc. (607378015) Establishment Name Address ID/FEI Business Operations Deb USA, Inc. 607378015 manufacture