Skip to Content

AMHEALER

Medically reviewed on June 25, 2018

Dosage form: spray
Ingredients: Sodium Fluoride 0.007mg in 35mL
Labeler: HEALINGAM CO., LTD
NDC Code: 69890-010

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.

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

AMHEALER 
sodium fluoride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69890-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (FLUORIDE ION) FLUORIDE ION0.007 mg  in 35 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Packaging
#Item CodePackage Description
1NDC:69890-010-0135 mL in 1 CARTON
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/FEIOperations
HEALINGAM CO., LTD689514353manufacture(69890-010)

 
HEALINGAM CO., LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide