Label: CLEAN HAND SANITIZER- ethyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58180-210-01 - Packager: Bicooya Cosmetics Limited
- 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 December 9, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAN HAND SANITIZER
ethyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58180-210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58180-210-01 10 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/09/2014 Labeler - Bicooya Cosmetics Limited (421310774) Registrant - Bicooya Cosmetics Limited (421310774) Establishment Name Address ID/FEI Business Operations Bicooya Cosmetics Limited 421310774 manufacture(58180-210)