Label: HARRIS ANTIBACTERIAL WIPES ANTISEPTIC HAND SANITIZER WIPES- benzalkonium chloride cloth
-
Contains inactivated NDC Code(s)
NDC Code(s): 80510-000-01, 80510-000-02 - Packager: TURKOSAN SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
- 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 March 22, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
- Package Labeling:72 wipes
- Package Labeling:102wipes
-
INGREDIENTS AND APPEARANCE
HARRIS ANTIBACTERIAL WIPES ANTISEPTIC HAND SANITIZER WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80510-000 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 BENZOIC ACID (UNII: 8SKN0B0MIM) C12-15 PARETH-12 (UNII: 131316X18L) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DEHYDROACETIC ACID (UNII: 2KAG279R6R) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80510-000-01 72 in 1 POUCH 05/10/2020 1 3.3 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:80510-000-02 102 in 1 POUCH 05/10/2020 2 3.4 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/10/2020 Labeler - TURKOSAN SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (533164108)