Label: HANDSOAP- chloroxylenol gel
- NDC Code(s): 47993-326-01, 47993-326-02
- Packager: NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD
- 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 June 17, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HANDSOAP
chloroxylenol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47993-326 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47993-326-01 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/15/2021 2 NDC:47993-326-02 1000 mL in 1 BAG; Type 0: Not a Combination Product 06/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/15/2021 Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491) Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)