Enamur Fluoride Anticavity Toothpaste

Enamur Fluoride Anticavity Toothpaste
SPL v4
SPL
SPL Set ID 557ced45-f54e-43d8-aa13-46f75b79367c
Route
ORAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.4 mg)
Inactive Ingredients
Glycerin Water Cellulose Gum Calcium Carboxymethyl Cellulose Hydrated Silica Cocamidopropyl Betaine Sodium Gluconate Carbomer 980 Sodium Benzoate Methyl Vinyl Ether And Maleic Acid Copolymer (1750000 Wamw) Poloxamer 407 Xanthan Gum Sodium Hydroxide Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Use

Helps protect against cavities

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away

Drug Fact 

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. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing habits (to minimize swallowing). Supervise children as nessary until capable of using without supervision. Children under 2 years ask a dentist or physician

Active Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

Glycerol, Water, Hydrated Silica, Crystalline Cellulose, Cellulose, Flavor, Cocamidopropyl Betaine, Sodium Gluconate, Carbomer, Sodium Benzoate, PVM/MA Copolymer, Poloxamer 407, Xanthan Gum, Sodium Hydroxide, Benzyl Alcohol.

Questions Or Comments ?

Principal Dispaly Panel 

ENAMUR           NDC 83610-1050-1

THE ClEANER CLEAN YOU CAN TRULY FEEL  

Fluoride AnitCavity Toothpaste

NET WT 5.2 OZ (147g)

Keep Out of the Reach of Children Under 6 Years of Age.


Structured Label Content

Use

Helps protect against cavities

Purpose

Anticavity

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away

Drug Fact 

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. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing habits (to minimize swallowing). Supervise children as nessary until capable of using without supervision. Children under 2 years ask a dentist or physician

Active Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

Glycerol, Water, Hydrated Silica, Crystalline Cellulose, Cellulose, Flavor, Cocamidopropyl Betaine, Sodium Gluconate, Carbomer, Sodium Benzoate, PVM/MA Copolymer, Poloxamer 407, Xanthan Gum, Sodium Hydroxide, Benzyl Alcohol.

Questions Or Comments ? (Questions or Comments ?)

Principal Dispaly Panel 

ENAMUR           NDC 83610-1050-1

THE ClEANER CLEAN YOU CAN TRULY FEEL  

Fluoride AnitCavity Toothpaste

NET WT 5.2 OZ (147g)

Keep Out of the Reach of Children Under 6 Years of Age. (Keep out of the reach of children under 6 years of age.)


Advanced Ingredient Data


Raw Label Data

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