PEANUTS ANTI-CAVITY FLUORIDE TOOTHPASTE- sodium fluoride paste

PEANUTS ANTI-CAVITY FLUORIDE TOOTHPASTE by

Drug Labeling and Warnings

PEANUTS ANTI-CAVITY FLUORIDE TOOTHPASTE by is a Otc medication manufactured, distributed, or labeled by American Sales Company, Dr. Fresh, Inc., Changzhou Daya Imp & Exp Corporation Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active Ingredient(s)                                          Purpose

Sodium Fluoride (0.24% w/w)
(0.15% w/v fluoride ion)                                    Anti-Cavity Toothpaste

PURPOSE

Purpose: Anti-cavity

INDICATIONS & USAGE

Uses

Aids in the prevention of dental cavities.

KEEP OUT OF REACH OF CHILDREN

Warnings:

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

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

Use a pea-sized amount for children under 6

Supervise children as necessary until capable of using without supervision

Children under 2 years of age: consult a dentist or physician.

INACTIVE INGREDIENT

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Glyerin, PEG-12, Cocamidopropyl Betaine, Flavor, Cellulose Gum, Trisodium Phosphate, Sodium Phosphate, Sodium Saccharin, Sodium Benzoate, Mica, Titanium Dioxide, Blue 1

QUESTIONS

Questions?

1-866-DRFRESH (373-7371)

SPL UNCLASSIFIED SECTION

Distributed by

American Sales Company

4201 Walden Avenue

Lancaster, NY 14086

(c) 2009 S and S Brands, Inc.

www.care1.info

Quality guaranteed or your money back.

ITEM# 71-05-43005-48

PRINCIPAL DISPLAY PANEL

www.snoopy.com

PEANUTS by Schull

Anti-Cavity Fluoride Toothpaste

Sparkling Bubble Gum Gel
Sugar Free

NET WT. 4.2 oz (119g)

CAREONE

Peanuts United Feature Syndicate, Inc.

Worldwide Patents Trademarks, and Copyright Pending and/or Granted. Made in PRC

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEANUTS ANTI-CAVITY FLUORIDE TOOTHPASTE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-878
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-878-14	119 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/13/2010

Labeler - American Sales Company (809183973)

Registrant - Dr. Fresh, Inc. (033059119)

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Daya Imp & Exp Corporation Ltd		421084500	manufacture