68599-0123

68599-0123
SPL v8
SPL
SPL Set ID 40057da9-2a4e-4bae-b5b4-606e9b757dc7
Route
DENTAL
Published
Effective Date 2012-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.43 mg)
Inactive Ingredients
Calcium Carbonate Water Sorbitol Hydrated Silica Glycerin Sodium Lauryl Sulfate Sodium Pyrophosphate Carboxymethylcellulose Sodium Benzoate Saccharin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2012-02-17 Until 2026-06-01
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Helps protect against cavities.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Section 51945-4

Principal Display Panel – 1.5 oz Case Label

Mint

Flavor

M c KESSON

Fluoride Toothpaste

1 Tube per Box, 1.5 oz

144 Boxes Per Case

Reorder No. 16-9571

Directions
  • Adults and children 2 years of age and older:Brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician.
  • Children under 6 years of age:Use a pea-sized amount to minimize swallowing and supervise child's brushing until good habits are established.
  • Children under 2 years of age:Ask a dentist or physician.
Active Ingredient

Sodium Monofluorophosphate 0.76% (0.122% w/v of fluoride ion)

Inactive Ingredients

calcium carbonate, purified water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxy methyl cellulose, sodium benzoate, sodium saccharin

Structured Label Content

Use

Helps protect against cavities.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Section 51945-4 (51945-4)

Principal Display Panel – 1.5 oz Case Label

Mint

Flavor

M c KESSON

Fluoride Toothpaste

1 Tube per Box, 1.5 oz

144 Boxes Per Case

Reorder No. 16-9571

Purpose

Anticavity

Directions
  • Adults and children 2 years of age and older:Brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician.
  • Children under 6 years of age:Use a pea-sized amount to minimize swallowing and supervise child's brushing until good habits are established.
  • Children under 2 years of age:Ask a dentist or physician.
Active Ingredient

Sodium Monofluorophosphate 0.76% (0.122% w/v of fluoride ion)

Inactive Ingredients (Inactive ingredients)

calcium carbonate, purified water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxy methyl cellulose, sodium benzoate, sodium saccharin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:44.957175 · Updated: 2026-03-14T23:03:58.855522