SHOPKINS MOUTH WASH- sodium fluoride liquid

Shopkins Mouth wash by

Drug Labeling and Warnings

Shopkins Mouth wash 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 0.5% (0.23% w/v fluoride ion) ......................... Anticavity

INDICATIONS & USAGE

Helps protect teeth and roots against cavities

WARNINGS

keep out of reach of children.

If you accidentally swallow seek medical help or contact a poison control center immediately

INACTIVE INGREDIENT

Water, Glycerine,PEG-40 Hydrogenated Castor Oil,Propylene Glycol,Xylitol,Benzyl Alcohol, Flavor, Sodium Benzoate, Sodium Saccharin, Zinc Gluconate, FD&C Red 40, D&C Red 33

DOSAGE & ADMINISTRATION

Adults and children 6 years and older:
Use daily after your normal brushing. Rinse toothpaste from your mouth prior to ouse.

Rinse or gargle for 30 seconds with 15ml (3 teaspoonful) and then spit it out.

Do not swallow the mouth wash

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHOPKINS MOUTH WASH 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-008
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CITRAL PROPYLENE GLYCOL ACETAL (UNII: 9W7YHX7EX6)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
WATER (UNII: 059QF0KO0R)
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)- (UNII: 3IIJ9C722I)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	red (FD & C Red 33) , red (FD &C Red 40)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-008-01	479 g in 1 TUBE; Type 0: Not a Combination Product	10/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/06/2016

Labeler - Ashtel Studios Inc. (148689180)

Establishment
Name	Address	ID/FEI	Business Operations
Dabur India Limited		650599231	manufacture(70108-008)