Label: MOUTH FRESH- cetylpyridinium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 51414-500-01, 51414-500-02, 51414-500-03, 51414-500-04, view more51414-500-05, 51414-500-06, 51414-500-07, 51414-500-08, 51414-500-09, 51414-500-10, 51414-500-11, 51414-500-12, 51414-500-13, 51414-500-14, 51414-500-15, 51414-500-16, 51414-500-17 - Packager: Yuyao Jessie Commodity Co.,Ltd.
- 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 September 12, 2012
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- Active Ingredient
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- WARNINGS
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOUTH FRESH
cetylpyridinium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51414-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.05 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) CHLOROMETHYL METHYL ETHER (UNII: 334G5B96VG) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) QUATERNIUM-15 (UNII: E40U03LEM0) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 20 (UNII: 7T1F30V5YH) CITRIC ACID ACETATE (UNII: DSO12WL7AU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51414-500-01 2 mL in 1 PACKAGE 2 NDC:51414-500-02 3 mL in 1 PACKAGE 3 NDC:51414-500-03 4 mL in 1 PACKAGE 4 NDC:51414-500-04 5 mL in 1 PACKAGE 5 NDC:51414-500-05 6 mL in 1 PACKAGE 6 NDC:51414-500-06 7 mL in 1 PACKAGE 7 NDC:51414-500-07 8 mL in 1 PACKAGE 8 NDC:51414-500-08 9 mL in 1 PACKAGE 9 NDC:51414-500-09 10 mL in 1 PACKAGE 10 NDC:51414-500-10 15 mL in 1 PACKAGE 11 NDC:51414-500-11 20 mL in 1 PACKAGE 12 NDC:51414-500-12 25 mL in 1 PACKAGE 13 NDC:51414-500-13 30 mL in 1 PACKAGE 14 NDC:51414-500-14 35 mL in 1 PACKAGE 15 NDC:51414-500-15 40 mL in 1 PACKAGE 16 NDC:51414-500-16 45 mL in 1 PACKAGE 17 NDC:51414-500-17 50 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/12/2012 Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305) Establishment Name Address ID/FEI Business Operations Yuyao Jessie Commodity Co.,Ltd. 529892305 manufacture(51414-500)