Label: SOOM MOUTHWASH- sodium fluoride, allantoin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 79717-0001-1 - Packager: TECOZYME INC
- 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 24, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOOM MOUTHWASH
sodium fluoride, allantoin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79717-0001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.02 g in 100 mL Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79717-0001-1 11 mL in 1 POUCH; Type 0: Not a Combination Product 07/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/24/2020 Labeler - TECOZYME INC (694613703) Registrant - TECOZYME INC (694613703) Establishment Name Address ID/FEI Business Operations TECOZYME INC 694613703 manufacture(79717-0001)