Label: ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER- polyhexamethylene biguanide gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 82658-002-01, 82658-002-02, 82658-002-03, 82658-002-04, view more82658-002-05, 82658-002-06, 82658-002-07, 82658-002-08 - Packager: Ningbo Meilei Electrical Appliance Co.,LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated March 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER
polyhexamethylene biguanide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82658-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE 9 g in 10000 g Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82658-002-01 40 g in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2022 2 NDC:82658-002-02 50 g in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2022 3 NDC:82658-002-03 60 g in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2022 4 NDC:82658-002-04 80 g in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2022 5 NDC:82658-002-05 100 g in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2022 6 NDC:82658-002-06 330 g in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2022 7 NDC:82658-002-07 360 g in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2022 8 NDC:82658-002-08 400 g in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/18/2022 Labeler - Ningbo Meilei Electrical Appliance Co.,LTD (540125107) Establishment Name Address ID/FEI Business Operations Ningbo Meilei Electrical Appliance Co.,LTD 540125107 manufacture(82658-002)
