Colgate 5g Toothbrush Kit
FDA Label NDC 72845-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wuhan Jinshengyuan Textiles Manufacturing Co., Ltd. for the product Colgate 5g Toothbrush Kit (NDC 72845-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, keep out of reach of children., directions, inactive ingredients, questions or comments?, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Anticavity

Use

Aids in the prevention of dental caries

helps protect against cavities

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinising habits (to minimize swallowing). Supervuse children as necessary until capable of using without supervision.
    • Children under 6 years of age: Consult a dentist or doctor.
      •  adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
       children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
       children under 2 years ask a dentist or physician

Inactive Ingredients

cellulose gum, dicalcium phosphate dihydrate, flavor, sodium lauryl sulfate, sodium saccharin, sorbitol, tetrasodium pyrophosphate, water

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions Or Comments?

1-800-468-6502

Call toll-free 1-800-468-6502

Keep Out Of The 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.

Package Labeling:42555-060-94

Colgate.5g (Colgate.5g)

Colgate.5g (Colgate.5g)

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