Label: FRESH PROTECT SKIN SANITIZER- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 20802-1501-1, 20802-1501-2, 20802-1501-3, 20802-1503-1 - Packager: Omega Tech Labs 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 January 2, 2011
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FRESH PROTECT SKIN SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20802-1501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.001 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) PUMMELO (UNII: ET1TN5W71X) THYMUS VULGARIS LEAF (UNII: GRX3499643) GREEN TEA LEAF (UNII: W2ZU1RY8B0) AVENA SATIVA LEAF (UNII: 206PI19V7R) PEPPERMINT OIL (UNII: AV092KU4JH) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20802-1501-1 50 mL in 1 BOTTLE 2 NDC:20802-1501-2 222 mL in 1 BOTTLE 3 NDC:20802-1501-3 800 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 12/16/2010 FRESH PROTECT SKIN SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20802-1503 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.001 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) PUMMELO (UNII: ET1TN5W71X) THYMUS VULGARIS LEAF (UNII: GRX3499643) GREEN TEA LEAF (UNII: W2ZU1RY8B0) AVENA SATIVA LEAF (UNII: 206PI19V7R) PEPPERMINT OIL (UNII: AV092KU4JH) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20802-1503-1 3785 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 12/16/2010 Labeler - Omega Tech Labs Inc. (019313817) Establishment Name Address ID/FEI Business Operations Omega Tech Labs Inc 019313817 MANUFACTURE