Label: HS75- alcohol gel
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NDC Code(s):
75512-008-01,
75512-008-02,
75512-008-03,
75512-008-04, view more75512-008-05
- Packager: Integrity Bio-Chemicals, 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 25, 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
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
HS75
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75512-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75512-008-01 3.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/20/2020 2 NDC:75512-008-02 18.95 L in 1 PAIL; Type 0: Not a Combination Product 05/20/2020 3 NDC:75512-008-03 208.45 L in 1 DRUM; Type 0: Not a Combination Product 05/20/2020 4 NDC:75512-008-04 1023.3 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 05/20/2020 5 NDC:75512-008-05 1231.75 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 05/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/20/2020 Labeler - Integrity Bio-Chemicals, LLC (080873668) Registrant - Integrity Bio-Chemicals, LLC (080873668) Establishment Name Address ID/FEI Business Operations Integrity Bio-Chemicals, LLC 080873668 manufacture(75512-008)