Label: ANTISEPTIC HAND SANITIZER- alcohol gel
- NDC Code(s): 65055-600-00, 65055-600-01, 65055-600-02
- Packager: Laboratorios Jaloma S.A. de C.V.
- 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 27, 2020
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
- Questions or comments?
- Package Labeling: (65055-600-00)
- Package Labeling: (65055-600-01)
- Package Labeling: (65055-600-02)
-
INGREDIENTS AND APPEARANCE
ANTISEPTIC HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65055-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65055-600-00 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2020 2 NDC:65055-600-01 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2020 3 NDC:65055-600-02 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/24/2020 Labeler - Laboratorios Jaloma S.A. de C.V. (811122357)