Label: PLAK SMACKER ANTI-CAVITY FLUORIDE GEL- sodium fluoride paste

  • Contains inactivated NDC Code(s)
    NDC Code(s):     71167-005-01, 71167-005-02, 71167-005-03, 71167-005-04, view more
    71167-005-05, 71167-005-06, 71167-005-07, 71167-005-08, 71167-005-09, 71167-005-10, 71167-005-11, 71167-005-12, 71167-005-13
  • Packager: HUAIAN ZONGHENG BIO-TECH CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 14, 2018

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  • Active Ingredient

    sodium fluoride 0.24%（0.14% w/v fluoride ion）

  • Purpose

    Anticavitytoothpaste

  • Use

    helps aid in the prevention of dental cavities.

  • Warning

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

  • Directions

    Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

    do not swallow

    to minimize swallowing use a pea-sized amount in children under 6

    supervise children as necessary until capable of using without supervision

  • Inactive Ingredients

    sorbitl,water,silicon dioxide,glycerin,saccharin sodium,PEG-8,sodium carboxymethyl cellulose ,lauryl sodium sulfate,aroma,sodium benzoate,ci42090anium Dioxide),Sodium saccharin,rose canina fruit oil

  • Keep out of reach of children under 6 years of age

    Keep out of reach of children under 6 years of age

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PLAK SMACKER ANTI-CAVITY FLUORIDE GEL 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71167-005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL, L- (UNII: 01Q0586BG1)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-8 DIOLEATE (UNII: 6JR5A7273E)  
    DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    AROMADENDRIN (UNII: 7YA4640575)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71167-005-01144 in 1 CARTON02/02/2018
    124 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71167-005-02120 in 1 CARTON02/02/2018
    224 in 1 BOX
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71167-005-04144 in 1 CARTON02/02/2018
    350 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:71167-005-0572 in 1 CARTON02/02/2018
    4100 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:71167-005-06144 in 1 BOX02/02/2018
    5100 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:71167-005-03120 in 1 CARTON02/02/2018
    624 in 1 BOX
    6120 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:71167-005-07480 in 1 BOX02/02/2018
    728 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:71167-005-0872 in 1 BOX02/02/2018
    8120 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:71167-005-09144 in 1 BOX02/02/2018
    9120 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:71167-005-10288 in 1 BOX02/02/2018
    1050 g in 1 TUBE; Type 0: Not a Combination Product
    11NDC:71167-005-11480 in 1 CARTON02/02/2018
    1124 in 1 BOX
    1128 g in 1 TUBE; Type 0: Not a Combination Product
    12NDC:71167-005-12576 in 1 CARTON02/02/2018
    12144 in 1 BOX
    1224 g in 1 TUBE; Type 0: Not a Combination Product
    13NDC:71167-005-1372 in 1 CARTON02/02/2018
    1312 in 1 BOX
    13120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/02/2018
    Labeler - HUAIAN ZONGHENG BIO-TECH CO., LTD (527152733)
    Establishment
    NameAddressID/FEIBusiness Operations
    HUAIAN ZONGHENG BIO-TECH CO., LTD527152733manufacture(71167-005)
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