Label: SPRINJENE- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 63404-0720-1, 63404-0720-2, 63404-0720-3, 63404-0720-4 - Packager: Health and Natural Beauty USA Corp
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated July 22, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 80 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SPRINJENE
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63404-0720 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) Glycerin (UNII: PDC6A3C0OX) Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) TRIETHYLENE AMINE (UNII: VG267KM5GH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63404-0720-1 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/01/2020 2 NDC:63404-0720-2 300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/01/2020 3 NDC:63404-0720-3 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/01/2020 4 NDC:63404-0720-4 80 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 08/01/2020 Labeler - Health and Natural Beauty USA Corp (079129688) Establishment Name Address ID/FEI Business Operations Health and Natural Beauty USA Corp 079129688 MANUFACTURE(63404-0720)