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

Purpose

Anticavity Toothpaste

Description

Drug Facts


Medication Information

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
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

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
Active Ingredient

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

Principal Display Panel 43 G Tube Carton




Structured Label Content

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
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

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
Active Ingredient (Active ingredient)

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

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




Advanced Ingredient Data


Raw Label Data

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