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Complete care whole mouth protection - Medication Information

Product NDC Code 10237-675
Drug Name

Complete care whole mouth protection

Type Brand
Active Ingredients
Sodium fluoride 1.5 mg/g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 416783
Application Number part355
Labeler Name Church & Dwight Co., Inc.
Packages
Package NDC Code Description
10237-675-09 1 tube in 1 carton (10237-675-09) / 25.5 g in 1 tube
10237-675-12 1 tube in 1 carton (10237-675-12) / 340 g in 1 tube
10237-675-60 1 tube in 1 carton (10237-675-60) / 170 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Sodium fluoride 0.24% (0.15% 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 Directions do not swallow • supervise children as necessary until capable of using without supervision • rinse away toothpaste residue throughly after brushing 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 or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician
adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, flavor, sodium lauryl sulfate, sodium lauroyl sarcosinate, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide

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.
aids in the prevention of dental decay

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Complete Care Whole Mouth Protection Sodium Fluoride SODIUM BICARBONATE POLYETHYLENE GLYCOL 400 WATER SACCHARIN SODIUM SODIUM PYROPHOSPHATE SODIUM LAURYL SULFATE SODIUM LAUROYL SARCOSINATE HYDRATED SILICA XANTHAN GUM TITANIUM DIOXIDE SORBITOL GLYCERIN SODIUM FLUORIDE FLUORIDE ION Fresh Mint

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 Great New Formula! Anticavity Fluoride Toothpaste ARM AND HAMMER The Standard of Purity UP TO 3X MORE PLAQUE REMOVAL* COMPLETE CARE™ whole mouth protection provides deep cleaning, whitening & gum health fresh mint ULTRA SMOOTH FORMULA NET WT. 6.0 OZ. (170g) AH Complete Care Artwork.jpg

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if irritation occurs and persists.

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 under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-800-786-513 5 Mon.-Fri. 9am-5pm ET or visit www.myoralcare.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 Do not use if irritation occurs and persists. Do not use if irritation occurs and persists. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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