DECURE- sodium monofluorophosphate paste, dentifrice

DeCure by

Drug Labeling and Warnings

DeCure by is a Otc medication manufactured, distributed, or labeled by Scope medical devices private limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity (Total Fluoride Content - 1000 ppm Approx.)

Uses:

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

Warnings:

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.

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.

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

SPL UNCLASSIFIED SECTION

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.

Packaging

INGREDIENTS AND APPEARANCE

DECURE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84132-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84132-100-10	10 g in 1 TUBE; Type 0: Not a Combination Product	05/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/11/2024

Labeler - Scope medical devices private limited (872194617)