SPL v4
SPL
SPL Set ID 4c0970e9-7417-4234-89e3-3b602a609af5
Route
ORAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Sorbitol Hydrated Silica Water Glycerin Polyethylene Glycol 600 Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Sodium Benzoate Sodium Phosphate, Dibasic, Dihydrate Saccharin Sodium Fd&c Blue No. 1 Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

Purpose

Anticavity Toothpaste


Medication Information

Purpose

Anticavity Toothpaste

Description

Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

Use

Use - Helps protect against cavities

Warnings

If you accidentally swallow more than used for brushing get medical help or contact a poison control center immediately.

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 doctor. 

Children under 6 years of age.  Use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing.  Supervise children as necessary until capable of using without supervision.

Product Labels

OraLine Fluoride Toothpaste  ADA accepted.The ADA Council on Scientific Affairs Acceptance of OraLine Fluoride Mint Toothpaste is based on finding that the product is effective in helping to prevent and reduce tooth decay when used as directed

No animal based ingredients.  Mint Flavor  Net Wt 3 oz (85 g)

res

Active Ingredient

Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

Inactive Ingredients

Sorbitol, Hydrated Silica, DI Water, Glycerin, PEG 600, Sodium Lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Sodium Saccharin, FD C Blue 1

Keep Out of Reach of Children

Children under 2 years of age consult a doctor or a dentist

Keep out of the reach of children under 6 years of age.


Structured Label Content

Use

Use - Helps protect against cavities

Purpose

Anticavity Toothpaste

Warnings

If you accidentally swallow more than used for brushing get medical help or contact a poison control center immediately.

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 doctor. 

Children under 6 years of age.  Use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing.  Supervise children as necessary until capable of using without supervision.

Product Labels

OraLine Fluoride Toothpaste  ADA accepted.The ADA Council on Scientific Affairs Acceptance of OraLine Fluoride Mint Toothpaste is based on finding that the product is effective in helping to prevent and reduce tooth decay when used as directed

No animal based ingredients.  Mint Flavor  Net Wt 3 oz (85 g)

res

Active Ingredient

Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

Inactive Ingredients

Sorbitol, Hydrated Silica, DI Water, Glycerin, PEG 600, Sodium Lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Sodium Saccharin, FD C Blue 1

Keep Out of Reach of Children

Children under 2 years of age consult a doctor or a dentist

Keep out of the reach of children under 6 years of age.


Advanced Ingredient Data


Raw Label Data

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