Label: HOLOI- alcohol liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 78483-001-01, 78483-001-02, 78483-001-03, 78483-001-04 - Packager: LIFEN1 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 June 2, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package label principle display panel
-
INGREDIENTS AND APPEARANCE
HOLOI
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78483-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78483-001-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/02/2020 2 NDC:78483-001-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/02/2020 3 NDC:78483-001-03 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/02/2020 4 NDC:78483-001-04 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/02/2020 Labeler - LIFEN1 LLC (114893046)
