PINE SALT- sodium fluoride paste, dentifrice

Pine Salt by

Drug Labeling and Warnings

Pine Salt by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Toothpaste

INGREDIENTS AND APPEARANCE

PINE SALT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0043
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0043-6	1 in 1 BOX
1		170 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/22/2011

Labeler - Kareway Product, Inc. (121840057)