Freshmint Anticavity Fluoride Gel Toothpaste
FDA Label NDC 68747-6027

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dabur India Limited for the product Freshmint Anticavity Fluoride Gel Toothpaste (NDC 68747-6027). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, adults & children 6 years of age & older:, children 2 to 6 years:, children under 2 years:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Adults & Children 6 Years Of Age & Older:

→ Children 2 To 6 Years:

→ Children Under 2 Years:

→ Inactive Ingredients

→ Package Label.principal Display Panel

Other

NET WT. 6.4 OZ

(181 GRAMS)

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 right away.

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

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