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Avon whitening essentials original cool mint - Medication Information

Product NDC Code 43136-901
Drug Name

Avon whitening essentials original cool mint

Type Brand
Active Ingredients
Sodium fluoride 1.6 mg/g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 891775
Application Number part355
Labeler Name Tai Guk Pharm. Co., Ltd.
Packages
Package NDC Code Description
43136-901-01 1 tube in 1 carton (43136-901-01) / 156 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Sodium fluoride 0.243% (0.16% w/v fluoride ion)

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.
Directions Adults and children 6 years and older Brush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow. Children between 6 and 12 years To minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. Children under 6 years Ask a dentist or physician.
Adults and children 6 years and older Brush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow.
Children between 6 and 12 years To minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
Children under 6 years Ask a dentist or physician.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica, charcoal powder, citrus limon(lemon) fruit extract, sodium chloride

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.
Use helps protect against cavities

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
AVON Whitening Essentials Original Cool Mint Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION HEXASODIUM HEXAMETAPHOSPHATE GLYCERIN WATER POLYETHYLENE GLYCOL 300 SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SODIUM LAURYL SULFATE CARRAGEENAN COCAMIDOPROPYL BETAINE SACCHARIN SODIUM SACCHARIN SUCRALOSE TITANIUM DIOXIDE HYDRATED SILICA XANTHAN GUM MICA CITRUS LIMON FRUIT OIL ACTIVATED CHARCOAL SODIUM CHLORIDE Cool

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.
Principal Display Panel - 156 g Tube Carton AVON Whitening Essentials FLUORIDE TOOTHPASTE CAVITY PROTECTION HELPS WHITEN TEETH - REMOVES SURFACE STAINS ORIGINAL COOL MINT NET WT 5.5 oz (156 g) COOLMINT

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Drug Facts

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. Keep out of reach of children under 6 years of age. Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If an allergic reaction develops, discontinue to use immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
1-800-FOR-AVON www.avon.com

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.
Warnings Warnings Keep out of reach of children. Keep out of reach of children under 6 years of age. Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If an allergic reaction develops, discontinue to use 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