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Far Infra Silver

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 0.76g in 100g
Labeler: Jewoo Medical Co., Ltd.
NDC Code: 69653-010

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 Monofluorophosphate 0.76%

INACTIVE INGREDIENT

Inactive ingredients: Silica, Dental type silica, 6-Aminocaproic Acid, Allantoine Chlorohydroxy Aluminum, Glycerin, Polyethylene Glycol 1500, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Xylitol, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, L-Menthol, Peppermint Oil, Carvone, Anethole, Silver, Mica, CI 42090, Purified Water

PURPOSE

Purpose : Anticavity

WARNINGS

Warnings: If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of the reach of children under 6 years of age.

INDICATIONS & USAGE

Indications & usage: help protect against gum disease and cavities.

DOSAGE & ADMINISTRATION

Dosage & administration:

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

children under 2 years: ask a dentist or physician.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAR INFRA SILVER 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69653-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (FLUORIDE ION) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Packaging
#Item CodePackage Description
1NDC:69653-010-01100 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2015
Labeler - Jewoo Medical Co., Ltd. (689512541)
Registrant - Jewoo Medical Co., Ltd. (689512541)
Establishment
NameAddressID/FEIOperations
Jewoo Medical Co., Ltd.689512541manufacture(69653-010)

Revised: 03/2015
 
Jewoo Medical 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.

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