Decure

Decure
SPL v1
SPL
SPL Set ID 590c4827-f036-45bd-af30-0a4853ca3447
Route
DENTAL
Published
Effective Date 2024-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Carbonate Water Sorbitol Silicon Dioxide Sodium Lauryl Sulfate Sodium Silicate Sodium Pyrophosphate Carboxymethylcellulose Sodium, Unspecified Xanthan Gum Benzyl Alcohol Saccharin Sodium Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-11
Description

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity (Total Fluoride Content - 1000 ppm Approx.)

Medication Information

Purpose

Anticavity (Total Fluoride Content - 1000 ppm Approx.)

Description

Sodium Monofluorophosphate 0.76%

Uses:

Regular brushing with Fluoride toothpaste helps protect teeth roots against cavities.

Section 42229-5

With Fluoride Anticavity Protection

Manufactured For:

Scope Medical Devices Pvt. Ltd.

11/10, Mandhour Industrial Area,

Ambala -134003, India

Factory Neutral Code

DNH/COS/DNH/52

Ref # :330139

Made in India

Exp. Date & Batch No. on crimp.

Section 50565-1

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

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Packaging

Warnings:

Drug Facts

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 yrs. To minimize swallowing use a pea - sized amount and supervise brushing until good habits are established.
Children under 2 yrs. Ask a dentist or physician.

Active Ingredients:

Sodium Monofluorophosphate 0.76%

Inactive Ingredients:

Calcium Carbonate, Water, Sorbitol, Silica, Sodium Lauryl Sulphate, Flavor, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate

Structured Label Content

Uses:

Regular brushing with Fluoride toothpaste helps protect teeth roots against cavities.

Section 42229-5 (42229-5)

With Fluoride Anticavity Protection

Manufactured For:

Scope Medical Devices Pvt. Ltd.

11/10, Mandhour Industrial Area,

Ambala -134003, India

Factory Neutral Code

DNH/COS/DNH/52

Ref # :330139

Made in India

Exp. Date & Batch No. on crimp.

Section 50565-1 (50565-1)

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

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Purpose

Anticavity (Total Fluoride Content - 1000 ppm Approx.)

Packaging

Warnings:

Drug Facts

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 yrs. To minimize swallowing use a pea - sized amount and supervise brushing until good habits are established.
Children under 2 yrs. Ask a dentist or physician.

Active Ingredients:

Sodium Monofluorophosphate 0.76%

Inactive Ingredients:

Calcium Carbonate, Water, Sorbitol, Silica, Sodium Lauryl Sulphate, Flavor, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.041361 · Updated: 2026-03-14T23:03:09.210552