Label: SHING-RELEEV- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63287-420-01, 63287-420-02 - Packager: Merix Pharmaceutical Corp.
- Category: HUMAN OTC DRUG LABEL
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 July 30, 2012
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INGREDIENTS AND APPEARANCE
SHING-RELEEV
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63287-420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg in 1 mL Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 5 mg in 1 mL Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH) Benzyl Alcohol 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Methylparaben (UNII: A2I8C7HI9T) Potassium Sorbate (UNII: 1VPU26JZZ4) Propylparaben (UNII: Z8IX2SC1OH) Echinacea purpurea flowering top (UNII: 2EMS3QFX65) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63287-420-02 1 in 1 BOX 1 NDC:63287-420-01 60 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 07/14/2010 Labeler - Merix Pharmaceutical Corp. (158385687) Registrant - Topical Pharmaceutiocals Inc. (831530683) Establishment Name Address ID/FEI Business Operations Topical Pharmaceutiocals Inc. 831530683 manufacture(63287-420)