Livfresh Gum Protect Gel, Dentifrice
FDA Label NDC 87398-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Livionex Inc. for the product Livfresh Gum Protect (NDC 87398-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purposes, uses, stop use and consult a dentist if, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, Antigingivitis

Uses

  • aids in the prevention of cavities
  • helps prevent gingivitis and control bleeding gums
  • helps interfere with harmful effects of plaque associated with gingivitis

Stop Use And Consult A Dentist If

  • gingivitis, bleeding, or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children

younger than 12 years old. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age or older:

  • brush twice a day or as directed by a dentist
  • wet brush; apply a pea size amount to brush
  • do not wet brush after applying gel
  • brush thoroughly
  • spit and rinse
  • do not swallow
  • children under12 yrs: consult a dentist

Other Information

  • products containing stannous fluoride may produce surface staining of the teeth
  • adequate brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • this product is specially formulated to prevent staining
  • see your dentist regularly

Inactive Ingredients

Aqua, Sulfonylbismethane, Edathamil, Propylene Glycol, Peppermint, Sodium Cocoyl Isethionate, Carrageenan Gum, Stevia, Menthyl Lactate, Xanthan Gum, Menthol, Sodium Hydroxide, Brilliant Blue FCF

Questions?

1-408-884-1522 or
GetLIVFRESH.com

Package Label

CLINICALLY PROVEN 

LIVFRESH®     

Fluoride Gel Toothpaste for Anticavity & Antigingivitis

PLAQUE CONTROL ∙ HELPS REVERSE SIGNS OF GINGIVITIS ∙ PROTECTS ENAMEL

FLUORIDE + WHITENING

GUM
PROTECT +

HELPS
STOP GUM
BLEEDING

PEPPERMINT
FOAMING

NET WT 1.74 OZ (50g)

CONTROLS
PLAQUE
& HELPS
STOP GUM
BLEEDING

BEFORE
Yellow Bacterial Film
Plaque build up
Increased gum swelling & bleeding

BRUSH WITH LIVFRESH

AFTER
Bacteria Protective Barrier
Controls plaque
Reduces gum swelling & bleeding

Distributed by Livionex Inc.
Los Gatos, CA
Made in the USA

Carton Label (Cartonlabel)

Carton Label (Cartonlabel)

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