plak smacker great white shark anti-cavity

plak smacker great white shark anti-cavity
SPL v4
SPL
SPL Set ID ca5b91aa-f69c-4553-a2b6-acf0ca1d920e
Route
dental
Published
Effective Date 2023-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.4 mg)
Inactive Ingredients
carboxymethylcellulose raspberry polyethylene glycol 300 polyethylene glycol 1450 sodium lauryl sulfate methylparaben fd&c blue no. 1 propylparaben sorbitol hydrated silica saccharin sodium water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-05-27
Purpose

Anticavity toothpaste

Description

Sodium Fluoride 0.24% (0.14% w/v Fluoride ion)

Medication Information

Warnings

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.

Do not use if inner foil is torn, cut, or missing.

Purpose

Anticavity toothpaste

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 physician.
  • Do not swallow.
  • To minimize swallowing use a pea sized amount in children under 6 years.
  • Supervise children's brushing until good habits are established.
  • Children under 2 years of age, consult a dentist or physician.
Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue1

Description

Sodium Fluoride 0.24% (0.14% w/v Fluoride ion)

Use

Aids in the prevention of dental cavities.

Section 50565-1

Section 50570-1

Do not use if inner foil is torn, cut or missing.

Section 51945-4

PLAK SMACKER®

GREAT WHITE SHARK

NO SUGAR ADDED

COOL BERRY FLAVOR

ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

NET WT. 4.2oz (119g)

Active Ingredient

Sodium Fluoride 0.24%

(0.14% w/v Fluoride ion)

Questions Or Comments?

(800) 558-6684

Structured Label Content

Warnings

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.

Do not use if inner foil is torn, cut, or missing.

Purpose

Anticavity toothpaste

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 physician.
  • Do not swallow.
  • To minimize swallowing use a pea sized amount in children under 6 years.
  • Supervise children's brushing until good habits are established.
  • Children under 2 years of age, consult a dentist or physician.
Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue1

Use

Aids in the prevention of dental cavities.

Section 50565-1 (50565-1)

Section 50570-1 (50570-1)

Do not use if inner foil is torn, cut or missing.

Section 51945-4 (51945-4)

PLAK SMACKER®

GREAT WHITE SHARK

NO SUGAR ADDED

COOL BERRY FLAVOR

ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

NET WT. 4.2oz (119g)

Active Ingredient

Sodium Fluoride 0.24%

(0.14% w/v Fluoride ion)

Questions Or Comments? (Questions or comments?)

(800) 558-6684

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:23.590018 · Updated: 2026-03-14T23:13:25.872506