OROMIN- calcium chloride, sodium fluoride, sodium phosphate rinse
Germiphene Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ORO Min

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.

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.

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

500 mL 50 mL

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/16/2017

Labeler - Germiphene Corporation (206412512)

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