Label: FRUIT OF THE EARTH MEYER LEMON SCENTED ANTIBACTERIAL HAND WITH CANADIAN WILLOWHERB- benzethonium chloride soap
- NDC Code(s): 62217-085-87
- Packager: FRUIT OF THE EARTH, INC.
- 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 August 13, 2021
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- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of chlidren
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH MEYER LEMON SCENTED ANTIBACTERIAL HAND WITH CANADIAN WILLOWHERB
benzethonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-085 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) EDETATE SODIUM (UNII: MP1J8420LU) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-085-87 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/12/2021 Labeler - FRUIT OF THE EARTH, INC. (079559467)