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Far Infra Silver

Medically reviewed on March 26, 2018

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)

 
Jewoo Medical Co., Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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