Label: ALCOHOL WET WIPES- wet wipes swab
DISINFECTING WIPES- wet wipes swab
ANTIBACTERIAL WET WIPES- wet wipes swab
ALCOHOL WET TISSUE- wet tissue swab
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Contains inactivated NDC Code(s)
NDC Code(s): 74439-001-01, 74439-001-02, 74439-001-03, 74439-001-04, view more74439-001-05, 74439-001-06, 74439-001-07, 74439-001-08, 74439-002-01, 74439-003-01, 74439-003-02, 74439-003-03, 74439-004-01, 74439-004-02, 74439-004-03 - Packager: SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.
- 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 October 28, 2021
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INDICATIONS & USAGE
- PURPOSE
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALCOHOL WET WIPES
wet wipes swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74439-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 30 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.624 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL ALCOHOL (UNII: ND2M416302) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74439-002-01 50 g in 1 PACKET; Type 0: Not a Combination Product 04/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/13/2020 DISINFECTING WIPES
wet wipes swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74439-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 g CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.05 g in 100 g Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) WATER (UNII: 059QF0KO0R) CHLORPHENESIN (UNII: I670DAL4SZ) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74439-004-01 48 g in 1 PACKAGE; Type 0: Not a Combination Product 06/01/2020 2 NDC:74439-004-02 450 g in 1 PACKAGE; Type 0: Not a Combination Product 06/01/2020 3 NDC:74439-004-03 930 g in 1 CANISTER; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/13/2020 ANTIBACTERIAL WET WIPES
wet wipes swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74439-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.156 g in 100 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) BRONOPOL (UNII: 6PU1E16C9W) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74439-001-03 48 g in 1 PACKET; Type 0: Not a Combination Product 04/13/2020 2 NDC:74439-001-04 130 g in 1 PACKET; Type 0: Not a Combination Product 04/13/2020 3 NDC:74439-001-02 10 in 1 PACKET 04/13/2020 3 NDC:74439-001-01 5 g in 1 BAG; Type 1: Convenience Kit of Co-Package 4 NDC:74439-001-06 340 g in 1 PACKET; Type 0: Not a Combination Product 04/13/2020 5 NDC:74439-001-07 450 g in 1 PACKET; Type 0: Not a Combination Product 04/13/2020 6 NDC:74439-001-08 560 g in 1 CANISTER; Type 0: Not a Combination Product 04/13/2020 7 NDC:74439-001-05 286 g in 1 PACKET; Type 0: Not a Combination Product 04/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/13/2020 ALCOHOL WET TISSUE
wet tissue swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74439-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 g CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.05 g in 100 g Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) WATER (UNII: 059QF0KO0R) CHLORPHENESIN (UNII: I670DAL4SZ) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74439-003-01 48 g in 1 PACKAGE; Type 0: Not a Combination Product 06/01/2020 2 NDC:74439-003-02 450 g in 1 PACKAGE; Type 0: Not a Combination Product 06/01/2020 3 NDC:74439-003-03 930 g in 1 CANISTER; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/13/2020 Labeler - SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD. (421350449)
