dental kit - crest toothpaste

dental kit - crest toothpaste
SPL v4
SPL
SPL Set ID e05b59e4-6b4b-4c8d-965a-d5aa00345a08
Route
dental
Published
Effective Date 2014-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
water sorbitol hydrated silica sodium phosphate, dibasic, anhydrous xylitol sodium hydroxide cocamidopropyl betaine sodium laureth-2 phosphate saccharin sodium xanthan gum sucralose polyethylene oxide 900000 high density polyethylene mica titanium dioxide fd&c blue no. 1

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph final active Since 2014-12-23
Purpose

Anticavity toothpaste

Description

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Medication Information

Warnings

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Inactive Ingredients

water, sorbitol, hydrated silica, disodium pyrophosphate, xylitol, flavor, sodium hydroxide, cellulose gum, cocamidopropyl betaine, sodium laureth-2 phosphate, sodium saccharin, xanthan gum, carbomer, sucralose, polyethylene oxide, polyethylene, mica, titanium dioxide, blue 1 lake

Description

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Questions?

1-800-959-6586

Use

helps protect against cavities

Section 42229-5

Dist. by Procter & Gamble, Cincinnati, OH 45202

Package Labeling

Kit Package:

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Keep Out of Reach of Children Under 6 Yrs. of Age.

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

Structured Label Content

Warnings

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Inactive Ingredients

water, sorbitol, hydrated silica, disodium pyrophosphate, xylitol, flavor, sodium hydroxide, cellulose gum, cocamidopropyl betaine, sodium laureth-2 phosphate, sodium saccharin, xanthan gum, carbomer, sucralose, polyethylene oxide, polyethylene, mica, titanium dioxide, blue 1 lake

Questions?

1-800-959-6586

Use

helps protect against cavities

Section 42229-5 (42229-5)

Dist. by Procter & Gamble, Cincinnati, OH 45202

Package Labeling

Kit Package:

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Keep Out of Reach of Children Under 6 Yrs. of Age. (Keep out of reach of children under 6 yrs. of age.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:54.155650 · Updated: 2026-03-14T23:00:05.624312