Label: BODY LUXURIES FRENCH LAVENDER SCENTED WATERLESS ANTI BACTERIAL HAND GEL- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50563-149-01 - Packager: ENCHANTE ACCESSORIES 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 September 6, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BODY LUXURIES FRENCH LAVENDER SCENTED WATERLESS ANTI BACTERIAL HAND GEL
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-149 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 63 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 33.8 mL in 100 mL CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-149-01 90 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/09/2013 Labeler - ENCHANTE ACCESSORIES INC. (186050696) Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820) Establishment Name Address ID/FEI Business Operations Zhejiang Aidi Cosmetics Co., Ltd. 530876820 manufacture(50563-149)