Label: HYGIENI-KLEAN HAND SANITIZER FLUID HEALTHCARE GRADE- ipa liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78174-046-01, 78174-046-02, 78174-046-03, 78174-046-04, view more78174-046-05, 78174-046-06, 78174-046-07 - Packager: Custom Chemical Services, LLC
- Category: HUMAN OTC DRUG LABEL
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 February 18, 2021
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYGIENI-KLEAN HAND SANITIZER FLUID HEALTHCARE GRADE
ipa liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78174-046 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 80.1003 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.0662 L in 100 L water (UNII: 059QF0KO0R) 19.7930 L in 100 L POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) 0.0405 in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78174-046-01 3.78541 L in 1 JUG; Type 0: Not a Combination Product 01/09/2021 2 NDC:78174-046-02 0.946353 L in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2021 3 NDC:78174-046-03 0.473176 L in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2021 4 NDC:78174-046-04 0.354882 L in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2021 5 NDC:78174-046-05 0.236588 L in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2021 6 NDC:78174-046-06 0.118294 L in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2021 7 NDC:78174-046-07 0.0591471 L in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/09/2021 Labeler - Custom Chemical Services, LLC (078305908) Establishment Name Address ID/FEI Business Operations Custom Chemical Services, LLC 078305908 manufacture(78174-046)