Label: KLEAN GENIX HAND SANITIZER GEL FRESH- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78174-038-01, 78174-038-02, 78174-038-03, 78174-038-04, view more78174-038-05, 78174-038-06, 78174-038-07 - Packager: Custom Chemical Services, 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 April 27, 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
KLEAN GENIX HAND SANITIZER GEL FRESH
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78174-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70.0936 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.0678 L in 100 L water (UNII: 059QF0KO0R) 29.2745 L in 100 L AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) 0.3575 in 100 L FRAGRANCE CUCUMBER ALOE ORC1802955 (UNII: FSS3TH6V9M) 0.2066 in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78174-038-01 3.78541 L in 1 JUG; Type 0: Not a Combination Product 04/27/2021 2 NDC:78174-038-02 0.946353 L in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 3 NDC:78174-038-03 0.473176 L in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 4 NDC:78174-038-04 0.354882 L in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 5 NDC:78174-038-05 0.236588 L in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 6 NDC:78174-038-06 0.118294 L in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 7 NDC:78174-038-07 0.0591471 L in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/27/2021 Labeler - Custom Chemical Services, LLC (078305908) Establishment Name Address ID/FEI Business Operations Custom Chemical Services, LLC 078305908 manufacture(78174-038)