NATURES GUM BALM - sodium monofluorophosphate paste
Widepipe Corp

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.

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Drug Facts

Active ingredients
Sodium monofluorophosphate (0.84%)

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

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

Purpose

OTC toothpaste to clean teeth.

Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients water, sorbitol, glycerin. calcium pyrophosphate, hydrated silica, aluminum hydroxide, dicalcium phosphate, flavor, PEG-12, sodium lauryl sulfate, cellulose gum, trisodium phosphate, sodium phosphate, sodium saccharin, titanium dioxide

Apply small amount to toothbrush and brush alone gum lines for 2 minutes total time.

    Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or doctor
    instruct children under 6 years   in good brushing and rinsing habits (to minimize swallowing)
    supervise children as necessary until capable of using without supervision
    children under 2 years ask a dentist or physician

image of tube label

NATURES GUM BALM
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76454-100
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	8.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PHOSPHATE ION (UNII: NK08V8K8HR)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76454-100-01	75 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/01/2011	10/01/2018

Labeler - Widepipe Corp (029799329)

Name	Address	ID/FEI	Business Operations
Establishment
Widepipe Corp		029799329	relabel, label

Revised: 1/2012

Document Id: 698fa2f5-9044-430a-a8a0-aed3d056bd53

Set id: d82a07c3-4da0-4cf9-8084-79c92d36918e

Version: 1

Effective Time: 20120120

Widepipe Corp