Label: 2080 K ORIGINAL- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 71401-0007-1 - Packager: AK AMERICA
- 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 April 26, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
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INDICATIONS & USAGE
Do not swallow. Rinse mouth with water after brushing.
Children under 6 years:
- To minimize swallowing, use a pea-sized amount. Supervise brushing until good habits are established.
- If swallowed more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
2080 K ORIGINAL
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71401-0007 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.12 g in 120 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) 72 g in 120 g SODIUM LAURYL SULFATE (UNII: 368GB5141J) 3.12 g in 120 g CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 0.6 g in 120 g SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.156 g in 120 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.12 g in 120 g PHOSPHORIC ACID (UNII: E4GA8884NN) 22.8 g in 120 g WATER (UNII: 059QF0KO0R) 12.07 g in 120 g PANTHENOL (UNII: WV9CM0O67Z) 0.6 g in 120 g POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) 0.006 g in 120 g FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00156 g in 120 g SODIUM CHLORIDE (UNII: 451W47IQ8X) GINKGO (UNII: 19FUJ2C58T) ERYTHRITOL (UNII: RA96B954X6) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71401-0007-1 1 in 1 PACKAGE 01/02/2017 1 120 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/02/2017 Labeler - AK AMERICA (690064554) Establishment Name Address ID/FEI Business Operations AK AMERICA 690064554 relabel(71401-0007) Establishment Name Address ID/FEI Business Operations Aekyung Ind. Co., Ltd._Chungyang Factory 690511126 manufacture(71401-0007)