- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
- For external use only.
- Flammable. Keep away from open flame and sources of heat.
- Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label
-
INGREDIENTS AND APPEARANCE
SANI LUXE HAND SANITIZER WITH ALCOHOL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71489-007 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.625 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71489-007-01 284 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/24/2019 2 NDC:71489-007-02 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/25/2020 3 NDC:71489-007-03 59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/25/2020 4 NDC:71489-007-04 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/20/2020 5 NDC:71489-007-05 355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/25/2020 6 NDC:71489-007-06 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/25/2020 7 NDC:71489-007-07 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2020 8 NDC:71489-007-08 177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/25/2020 9 NDC:71489-007-09 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2020 10 NDC:71489-007-10 284 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2020 11 NDC:71489-007-11 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2020 12 NDC:71489-007-12 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/25/2020 13 NDC:71489-007-13 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/30/2020 14 NDC:71489-007-14 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 15 NDC:71489-007-15 530 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/14/2020 16 NDC:71489-007-16 530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/24/2019 Labeler - Celeste Industries Corporation (047795034)