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Shopkins mouth wash - Medication Information

Product NDC Code 70108-008
Drug Name

Shopkins mouth wash

Type Brand
Active Ingredients
Sodium fluoride .05 mg/100g
Route DENTAL
Dosage Form LIQUID
Application Number part355
Labeler Name Ashtel Studios Inc.
Packages
Package NDC Code Description
70108-008-01 479 g in 1 tube (70108-008-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Purpose Sodium Fluoride 0.5% (0.23% w/v fluoride ion) ......................... Anticavity

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Helps protect teeth and roots against cavities

Purpose

Information about the drug product’s indications for use.
Anticavity

Spl product data elements

Usually a list of ingredients in a drug product.
Shopkins Mouth wash Sodium Fluoride HYDROGENATED CASTOR OIL CITRAL PROPYLENE GLYCOL ACETAL ZINC GLUCONATE SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE WATER .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)- GLYCERIN XYLITOL SODIUM FLUORIDE FLUORIDE ION SODIUM BENZOATE SACCHARIN SODIUM FD & C Red 33 FD &C Red 40

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children . In case of accidental digestion seek professional assistance or contact a poison control center immediately.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
keep out of reach of children. If you accidentally swallow seek medical help or contact a poison control center immediately

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API