MAXIXUM SECURITY GEL TOOTHPASTE

Main information

  • Trade name:
  • MAXIXUM SECURITY GEL TOOTHPASTE- fluoride toothpaste paste, dentifrice
  • Composition:
  • SODIUM FLUORIDE 2.2 mg in 1 g
  • Administration route:
  • DENTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MAXIXUM SECURITY GEL TOOTHPASTE- fluoride toothpaste paste, dentifrice
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Anticavity. Helps protect against cavities.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 68747-6030-1
  • Last update:
  • 29-05-2019

Summary of Product characteristics: dosage, interactions, side effects

MAXIXUM SECURITY GEL TOOTHPASTE- fluoride toothpaste paste, dentifrice

Dabur India Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MAXIMUM SECURITY® GEL TOOTHPASTE

NET WT 4.6 OZ

DRUG FACTS:

ACTIVE INGREDIENT

Sodium fluoride- 0.22% (0.1% w/v fluoride ion)

PURPOSE

Anticavity.

USE

Helps protect against cavities.

WARNINGS

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally

swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS:

Adults & Children 6 years of age & 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 (to minimize swallowing).

Children under 2 years:

Ask a dentist or physician.

INACTIVE INGREDIENTS

Purified Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Poly Ethylene Glycol 1500,

Sodium Saccharin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Methyl Paraben, Propyl

Paraben.

Product of India,

Exclusive Distributor:

Bob Barker Co. Inc.,

Phone: 1-800-334-9880.

Expires: 3 years from the Date of Mfg.

C.No. DNH/COS/DNH/52

Mfg. Date & Batch No. on crimp.

24.06.2009

MAXIMUM SECURITY GEL TOOTHPASTE

ACTIVE INGREDIENT: SODIUM FLUORIDE - 0.22 %

(0.1% w/v fluoride Ion)

SR. NO. INGREDIENTS

1. Treated water

2. Sorbitol

3. Carbopol

4. Sodium lauryl sulphate

5. Flavor

6. Polyethylene glycol 1500

7. Sodium saccharin

8. Precipitated Silica

9. Sodium Carboxy Methyl Cellulose

10. Methyl Paraben

11. Propyl Paraben

Tube Label

MAXIMUM SECURITY®

GEL TOOTHPASTE

NET WT 4.6 0Z.(130g)

MAXIXUM SECURITY GEL TOOTHPASTE

fluoride toothpaste paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 747-6 0 30

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

SODIUM FLUORIDE

2.2 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Dabur India Limited

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

CARBO MER HO MO PO LYMER TYPE C (UNII: 4Q9 3RCW27E)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

PO LYETHYLENE GLYCO L 150 0 (UNII: 1212Z7S33A)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

MINT (MINT)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 747-6 0 30 -1

130 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 8 /25/20 0 9

Labeler -

Dabur India Limited (650319218)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dabur India Limited

6 50 319 218

MANUFACTURE

Revised: 8/2008