Label: BIG WIPES HEAVY DUTY- benzalkonium chloride cloth
- NDC Code(s): 79705-003-01, 79705-003-02, 79705-003-04, 79705-003-05
- Packager: Sycamore 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 November 23, 2022
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- Active Ingredient
- Purpose
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Inactive ingredients
WATER (AQUA), DIMETHYL SUCCINATE, DIMETHYL GLUTARATE, DIMETHYL ADIPATE, DIMETHYL METYLGLUTARATE, POLYSORBATE-80, POLYSORBATE-20, DIDECYLDIMONIUM CHLORIDE, GLYCERIN, METHYL SOYATE, PEG-75 LANOLIN, ALCOHOL, CITRIC ACID, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE (VITAMIN E), PROPANEDIOL, PARFUM.
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INGREDIENTS AND APPEARANCE
BIG WIPES HEAVY DUTY
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79705-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) METHYL SOYATE (UNII: 808DL597QP) PEG-75 LANOLIN (UNII: 09179OX7TB) DIMETHYL ADIPATE (UNII: BY71RX0R62) DIMETHYL METHYLGLUTARATE (UNII: 728OFW5M9G) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALCOHOL (UNII: 3K9958V90M) SODIUM CITRATE (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHYL SUCCINATE (UNII: 914I2127JR) DIMETHYL GLUTARATE (UNII: 1I9VFA346P) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYSORBATE 20 (UNII: 7T1F30V5YH) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79705-003-01 6 mL in 1 POUCH; Type 0: Not a Combination Product 08/28/2020 2 NDC:79705-003-02 123 mL in 1 CANISTER; Type 0: Not a Combination Product 08/28/2020 3 NDC:79705-003-04 464 mL in 1 CANISTER; Type 0: Not a Combination Product 08/28/2020 4 NDC:79705-003-05 1391 mL in 1 CANISTER; Type 0: Not a Combination Product 08/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/28/2020 10/31/2025 Labeler - Sycamore USA Inc. (078589316) Establishment Name Address ID/FEI Business Operations WET NAPS LTD. 514650902 manufacture(79705-003)
