Label: WHITE ORGANIA FRESH PURE HAND SANITIZER- ethanol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75312-0500-1 - Packager: WHITE COSPHARM 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 April 17, 2020
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INGREDIENTS AND APPEARANCE
WHITE ORGANIA FRESH PURE HAND SANITIZER
ethanol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75312-0500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 350 mL in 500 mL Inactive Ingredients Ingredient Name Strength AMINOMETHYLPROPANOL (UNII: LU49E6626Q) POLYSORBATE 20 (UNII: 7T1F30V5YH) GRAPEFRUIT (UNII: O82C39RR8C) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75312-0500-1 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/17/2020 Labeler - WHITE COSPHARM CO.,LTD. (688442259) Establishment Name Address ID/FEI Business Operations WHITE COSPHARM CO.,LTD. 688442259 manufacture(75312-0500)