Label: HAND SANITIZER EARTHZEN- hand saniziter earthzen gel
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Contains inactivated NDC Code(s)
NDC Code(s): 42955-011-01, 42955-011-02, 42955-011-03 - Packager: PROBEMEX S.A. DE CV
- 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 August 12, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGRIDIENT
- PURPOSE
- STOP USE
- WARNING
- DIRECTIONS
- INACTIVE
- WARNING
- DOSAGE
- KEEP OUT OF REACH
- PACKAGE
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INGREDIENTS AND APPEARANCE
HAND SANITIZER EARTHZEN
hand saniziter earthzen gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42955-011 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 AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.22 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.9 mL in 100 mL HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.14 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.001 mL in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 0.51 mL in 100 mL CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.33 mL in 100 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42955-011-01 52 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/12/2020 2 NDC:42955-011-03 1.5 mL in 1 DOSE PACK; Type 0: Not a Combination Product 08/12/2020 3 NDC:42955-011-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/12/2020 Labeler - PROBEMEX S.A. DE CV (813566395) Registrant - PROBEMEX S.A. DE CV (813566395) Establishment Name Address ID/FEI Business Operations PROBEMEX S.A. DE CV 813566395 manufacture(42955-011)