Label: HAND SANITIZER- alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 79882-001-01, 79882-001-02, 79882-001-03, 79882-001-04 - Packager: Solve Together, LLC
- 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 December 3, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use(s)
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79882-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79882-001-01 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2020 2 NDC:79882-001-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2020 3 NDC:79882-001-03 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2020 4 NDC:79882-001-04 3700 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 11/19/2020 Labeler - Solve Together, LLC (117539166) Establishment Name Address ID/FEI Business Operations Organikisimo, S.A. de C:V 951579669 MANUFACTURE(79882-001)