5820263 Heb Gleaming White Fresh Mint Anticavity Fluoride Toothpaste

5820263 Heb Gleaming White Fresh Mint Anticavity Fluoride Toothpaste
SPL v13
SPL
SPL Set ID 82491c8f-d2c2-2e4a-e053-2a91aa0a572f
Route
DENTAL
Published
Effective Date 2019-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Sodium Lauryl Sulfate Sorbitol Carboxymethylcellulose Sodium, Unspecified Form Sodium Hydroxide Saccharin Carbomer Homopolymer Type B (allyl Pentaerythritol Or Allyl Sucrose Crosslinked) Titanium Dioxide Fd&c Blue No. 1 Water Hydrated Silica Sodium Acid Pyrophosphate Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-12

Description

Active ingredient Sodium fluoride 0.243% (0.15% w/v fluoride ion)


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses aids in the prevention of dental cavities

Dosage and Administration

Directions

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor.

  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: consult a dentist or doctor.
Description

Active ingredient Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Section 42229-5

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

Section 44425-7

Other information Store in a cool, dry place. · Keep tube capped when not in use.

Section 50565-1

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.

Section 51727-6

Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

Section 51945-4

HEB®

Fresh Mint

GLEAMING WHITE

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT. 4.8 OZ (136g)

Section 53413-1

Questions or comments? CALL 1-877-777-2743

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)


Structured Label Content

Indications and Usage (34067-9)

Uses aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor.

  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: consult a dentist or doctor.
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

Section 44425-7 (44425-7)

Other information Store in a cool, dry place. · Keep tube capped when not in use.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

Section 51945-4 (51945-4)

HEB®

Fresh Mint

GLEAMING WHITE

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT. 4.8 OZ (136g)

Section 53413-1 (53413-1)

Questions or comments? CALL 1-877-777-2743

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)


Advanced Ingredient Data


Raw Label Data

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