SHOPKINS BRUSH BUDDIES- sodium fluoride paste

Shopkins Brush Buddies by

Drug Labeling and Warnings

Shopkins Brush Buddies by is a Otc medication manufactured, distributed, or labeled by Ashtel Studios Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental digestion seek professional assistance or contact a poison control center immediately.

ACTIVE INGREDIENT

Active Ingredient Purpose

Sodium Fluoride 0.243% (0.15% w/v fluoride ion) ......................... Anticavity

INDICATIONS & USAGE

Helps protect teeth and roots against cavities

WARNINGS

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

If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately

INACTIVE INGREDIENT

Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD & C Blue #1, FD &C Red # 40

DOSAGE & ADMINISTRATION

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.
Do not swallow
To minimize swallowing use a pea-sized amount in children under 6 years of age.
Supervise children's brushing until good habits are established.
Children under 2 years of age: Ask a dentist.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHOPKINS BRUSH BUDDIES 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
WATER (UNII: 059QF0KO0R)
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL (UNII: S8TT5K3C8Y)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	blue (F D & C Blue #1) , red (FD &C Red #4)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-005-01	119 g in 1 TUBE; Type 0: Not a Combination Product	07/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/22/2016

Labeler - Ashtel Studios Inc. (148689180)