PINE SALT - sodium fluoride paste, dentifrice 
Kareway Product, Inc.

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 ingredient

sodium fluoride 0.22%

Purpose

Anticavity

Uses

helps protect against cavities

Warnings

Enter section text here

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.

Directions

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

Inactive ingredients

di water, sorbitol, hydrated silica, sodium methyl cocoyl taurate, peg-32, sodium lauryl sulfate, baked sodium chloride, flavor, cellulose gum, songyum capsule, sodium saccharin, disodium phosphate, menthol capsule, methyl paraben, pine extract, tranexamic acid, yellow no.10, blue no.1

Package label

Pine Salt Toothpasteimage of toothpaste carton

PINE SALT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0043
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
PEG-32 STEARATE (UNII: 33GX5WQC0M)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PINUS STROBUS BARK (UNII: 8PJ4761097)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0043-61 in 1 BOX
1170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/22/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 8/2011
Document Id: feae241c-d9a2-4328-99bc-7a7e50e3b8d4
Set id: 69fa139f-e50f-498f-9aea-a2bb2c5a52bf
Version: 1
Effective Time: 20110819
 
Kareway Product, Inc.