4871 Morning Fresh Mint Toothpaste, With Fluoride Ndc # 67777-190-02

4871 Morning Fresh Mint Toothpaste, With Fluoride Ndc # 67777-190-02
SPL v2
SPL
SPL Set ID 2a42d8ce-e7f2-caa5-e063-6294a90ac01f
Route
DENTAL
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.3 mg)
Inactive Ingredients
Sodium Silicate Water Calcium Carbonate Sodium Lauryl Sulfate Methylparaben Propylparaben Sodium Benzoate Saccharin Sodium Sorbitol Carboxymethylcellulose Sodium, Unspecified Silicon Dioxide Titanium Dioxide Peppermint Oil Polyethylene Glycol 400 Sodium Pyrophosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-15

Description

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Label

4871 Label

Use(s)

Helps protect against cavities

Warning

Do Not Swallow

Directions

• Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: to minimize swallowing, use a pea size amount and supervise brushing and rinsing until good habits are established.

• Children under 2 years: Use as directed by a dentist or physician.

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Other Information

Store between 15º - 35ºC (59º - 95ºF)

Inactive Ingredients

Calcium Carbonate, Carboxymethylcellulose Sodium, Methylparaben, Peppermint Oil, Polyethylene Glycol 400, Propylparaben, Purified Water, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Pyrophosphate, Sodium Silicate, Sorbitol, Titanium Dioxide

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 (1-800-222-1222) immediately.


Structured Label Content

Label

4871 Label

Use(s)

Helps protect against cavities

Purpose

Anticavity

Warning

Do Not Swallow

Directions

• Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: to minimize swallowing, use a pea size amount and supervise brushing and rinsing until good habits are established.

• Children under 2 years: Use as directed by a dentist or physician.

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Other Information

Store between 15º - 35ºC (59º - 95ºF)

Inactive Ingredients

Calcium Carbonate, Carboxymethylcellulose Sodium, Methylparaben, Peppermint Oil, Polyethylene Glycol 400, Propylparaben, Purified Water, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Pyrophosphate, Sodium Silicate, Sorbitol, Titanium Dioxide

Keep Out of Reach of Children Under 6 Years of Age (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 (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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