Label: HYGIENI-KLEAN HAND SANITIZER GEL LAVENDER- ipa gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78174-021-01, 78174-021-02, 78174-021-03, 78174-021-04, view more78174-021-05, 78174-021-06, 78174-021-07 - 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 February 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 GEL LAVENDER
ipa gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78174-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75.015 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.067 L in 100 L POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) 0.0409 L in 100 L AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) 0.3974 in 100 L water (UNII: 059QF0KO0R) 24.398 L in 100 L FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5) 0.0818 in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78174-021-01 3.78541 L in 1 JUG; Type 0: Not a Combination Product 01/06/2021 2 NDC:78174-021-02 0.946353 L in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2021 3 NDC:78174-021-03 0.473176 L in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2021 4 NDC:78174-021-04 0.354882 L in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2021 5 NDC:78174-021-05 0.236588 L in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2021 6 NDC:78174-021-06 0.118294 L in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2021 7 NDC:78174-021-07 0.0591471 L in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/06/2021 Labeler - Custom Chemical Services, LLC (078305908) Establishment Name Address ID/FEI Business Operations Custom Chemical Services, LLC 078305908 manufacture(78174-021)