Label: CARIBBEAN ESCAPE ANTI BACTERIAL HAND SANITIZER- benzethonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59021-008-01 - Packager: Five Below
- 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 12, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CARIBBEAN ESCAPE ANTI BACTERIAL HAND SANITIZER
benzethonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59021-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 82 g in 100 mL CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) TROLAMINE (UNII: 9O3K93S3TK) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 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:59021-008-01 225 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/12/2013 Labeler - Five Below (095446659) Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820) Establishment Name Address ID/FEI Business Operations Zhejiang Aidi Cosmetics Co., Ltd. 530876820 manufacture(59021-008)