Label: AMBER MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50438-303-01 - Packager: Filo America
- 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 July 30, 2013
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- ACTIVE INGREDIENT
- USES
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WARNINGS
DO NOT USE IF YOU HAVE PAINFUL OR SWOLLEN GUM LINE, LOOSE TEETH OR INCREASED SPACING BETWEEN THE TEETH. SEE YOUR DENTIST IMMEDIATELY. THESE MAY BE SIGNS OF PERIODONTITIS, A SERIOUS FORM OF GUM DISEASE.
DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE.
STOP USE AND ASK A DENTIST IF GINGIVITIS, BLEEDING OR REDNESS PERSISTS FOR MORE THAN 72 HOURS.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMBER MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-303 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.92 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.42 mg in 1 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.6 mg in 1 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50438-303-01 500 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/30/2013 Labeler - Filo America (943873703) Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(50438-303)