OROMIN- calcium chloride, sodium fluoride, sodium phosphate rinse

OroMin by

Drug Labeling and Warnings

OroMin by is a Otc medication manufactured, distributed, or labeled by Germiphene Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Recommended use:

Oro Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

PURPOSE

ORO Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

Medicinal ingredient:

Calcium chloride 0.054%, sodium fluoride 0.02%, sodium phosphate 0.056%

Non-Medicinal Ingredients:

Water, ethyl alcohol, sorbitol solution, sodium chloride, edetate disodium, sodium benzoate, polysorbate 20, polysorbate 80, methyl paraben, sodium saccharin, propyl paraben, and flavouring agent.

Directions:

After brushing and flossing, rinse 10-15 mL of ORO Min (fill cap 3/4 full) between teeth for 60 seconds, then spit out. Do not swallow. Do not eat or drink for 30 minutes after rinsing. Use twice a day or as directed by your dentist or hygienist.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS

Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OROMIN 
calcium chloride, sodium fluoride, sodium phosphate rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61508-0200
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC	0.056 g  in 100 g
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CHLORIDE	0.054 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.01 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	2 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.005 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.06 g  in 100 g
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)	0.137 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.877 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	0.025 g  in 100 g
WATER (UNII: 059QF0KO0R)	94.9 g  in 100 g
SORBITOL (UNII: 506T60A25R)	1.5 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	0.1 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.1 g  in 100 g
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.1 g  in 100 g

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61508-0200-1	500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2017
2	NDC: 61508-0200-2	50 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/16/2017

Labeler - Germiphene Corporation (206412512)

Establishment
Name	Address	ID/FEI	Business Operations
Germiphene Corporation		206412512	manufacture(61508-0200)