AMHEALER- sodium fluoride spray 
HEALINGAM CO., LTD

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.

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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

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)

Revised: 6/2015
Document Id: fdc7b831-f053-41f5-b013-3b5bee4444e6
Set id: 81817163-a5b5-4eaa-b014-085c6098d022
Version: 1
Effective Time: 20150623
 
HEALINGAM CO., LTD