Ancalima- Good Morning

Ancalima- Good Morning
SPL v1
SPL
SPL Set ID c2b1f15a-d754-90fa-e053-2a95a90ab69e
Route
DENTAL
Published
Effective Date 2018-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Calcium Carbonate Water Sorbitol Hydrated Silica Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Form Saccharin Sodium Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-01-15
Description

Drug Facts

Purpose

Anticavity Toothpaste

Medication Information

Purpose

Anticavity Toothpaste

Description

Drug Facts

Use

aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

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 immediately
Directions
  • Do not Swallow
  • Supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
  • Adults and children 6 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 under 6 years of age: Do not use unless directed by a dentist or physician
Active Ingredient

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Other Information
  • Store at 59°-86°F (15°-30°C)
  • Avoid excessive heat
Inactive Ingredients

Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben

Principal Display Panel 43 G Tube Carton



Structured Label Content

Use

aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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 immediately
Purpose

Anticavity Toothpaste

Directions
  • Do not Swallow
  • Supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
  • Adults and children 6 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 under 6 years of age: Do not use unless directed by a dentist or physician
Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Other Information
  • Store at 59°-86°F (15°-30°C)
  • Avoid excessive heat
Inactive Ingredients

Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben

Principal Display Panel 43 G Tube Carton (PRINCIPAL DISPLAY PANEL - 43 g Tube Carton)



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:33.693249 · Updated: 2026-03-14T22:59:36.331864