Freshmint®

Freshmint®
SPL v1
SPL
SPL Set ID 4cc7df92-bb2b-49a4-aa5e-41c6bb1108ef
Route
DENTAL
Published
Effective Date 2008-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.2 mg)
Inactive Ingredients
Water Sorbitol Carbomer Homopolymer Type C Sodium Lauryl Sulfate Polyethylene Glycol 1500 Saccharin Sodium Silicon Dioxide Carboxymethylcellulose Sodium Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-08-25

Description

NET WT. 6.4 OZ (181 GRAMS)

Purpose

Anticavity.


Medication Information

Purpose

Anticavity.

Description

NET WT. 6.4 OZ (181 GRAMS)

Use

Helps protect against cavities.

Section 42229-5

NET WT. 6.4 OZ

(181 GRAMS)

Section 51945-4

Principal Display Panel

Tube Label

freshmint®

ANTICAVITY FLUORIDE GEL TOOTHPASTE

NET WT. 6.4 OZ

(181 GRAMS)

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 right away.

Active Ingredient

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

Inactive Ingredients

Treated 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

New World Imports, Inc.

160 Athens Way

Nashville, TN 37228.

Expires: 3 years from the Date of Mfg.

C. No. DNH/COS/DNH/52Mfg.

Date & Batch No. on crimp.

24.06.2009

FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE

ACTIVE INGREDIENT: SODIUM FLUORIDE - 0.22 %

(0.1% w/v fluoride Ion)

SR. NO. INGREDIENTS

  • Treated water
  • Sorbitol
  • Carbopol
  • Sodium lauryl sulphate
  • Flavor
  • Polyethylene glycol 1500
  • Sodium saccharin
  • Precipitated Silica
  • Sodium Carboxy Methyl Cellulose
  • Methyl Paraben
  • Propyl Paraben
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.

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.


Structured Label Content

Use (USE)

Helps protect against cavities.

Section 42229-5 (42229-5)

NET WT. 6.4 OZ

(181 GRAMS)

Section 51945-4 (51945-4)

Principal Display Panel

Tube Label

freshmint®

ANTICAVITY FLUORIDE GEL TOOTHPASTE

NET WT. 6.4 OZ

(181 GRAMS)

Purpose (PURPOSE)

Anticavity.

Warnings (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 right away.

Active Ingredient (ACTIVE INGREDIENT)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Treated 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

New World Imports, Inc.

160 Athens Way

Nashville, TN 37228.

Expires: 3 years from the Date of Mfg.

C. No. DNH/COS/DNH/52Mfg.

Date & Batch No. on crimp.

24.06.2009

FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE

ACTIVE INGREDIENT: SODIUM FLUORIDE - 0.22 %

(0.1% w/v fluoride Ion)

SR. NO. INGREDIENTS

  • Treated water
  • Sorbitol
  • Carbopol
  • Sodium lauryl sulphate
  • Flavor
  • Polyethylene glycol 1500
  • Sodium saccharin
  • Precipitated Silica
  • Sodium Carboxy Methyl Cellulose
  • Methyl Paraben
  • Propyl Paraben
Children 2 to 6 Years: (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: (Children under 2 years:)

Ask a dentist or physician.

Adults & Children 6 Years of Age & Older: (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.


Advanced Ingredient Data


Raw Label Data

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