AMHEALER- sodium fluoride spray

AMHEALER by

Drug Labeling and Warnings

AMHEALER by is a Otc medication manufactured, distributed, or labeled by HEALINGAM CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AMHEALER 
sodium fluoride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69890-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.007 mg  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69890-010-01	35 mL in 1 CARTON; 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	05/01/2015

Labeler - HEALINGAM CO., LTD (689514353)

Registrant - HEALINGAM CO., LTD (689514353)

Establishment
Name	Address	ID/FEI	Business Operations
HEALINGAM CO., LTD		689514353	manufacture(69890-010)