Label: AMHEALER- sodium fluoride spray

  • 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 June 23, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Fluoride 0.02%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Thiobacillus

  • PURPOSE

    Purpose: Bad breath removal

  • WARNINGS

    Warnings: 1. Keep out of reach of babies and children 2. Keep away from direct sunlight

  • KEEP OUT OF REACH OF CHILDREN

    1. Keep out of reach of babies and children

  • INDICATIONS & USAGE

    Indications & Usage: Open the container cap and press the spray button(1~2 times)

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Do not use more than 5㎖ per day (50 times)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    AMHEALER 
    sodium fluoride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69890-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.007 mg  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69890-010-0135 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2015
    Labeler - HEALINGAM CO., LTD (689514353)
    Registrant - HEALINGAM CO., LTD (689514353)
    Establishment
    NameAddressID/FEIBusiness Operations
    HEALINGAM CO., LTD689514353manufacture(69890-010)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!