5820020 Heb Dry Mouth

5820020 Heb Dry Mouth
SPL v15
SPL
SPL Set ID 8254eae7-8e3b-a9df-e053-2a91aa0abb98
Route
DENTAL
Published
Effective Date 2019-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Glycerin Saccharin Sodium Water Sodium Hydroxide Titanium Dioxide Sucralose Hydrated Silica Cocamidopropyl Betaine Sorbitol Polyethylene Glycol, Unspecified Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-20 Until 2025-11-01

Description

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


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use

  • aids in the prevention of dental cavities
Dosage and Administration

Directions

Adults and children 12 years of age and older: Apply onto a soft bristle toothbrush.

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician.

Children under 12 years of age: consult a dentist or physician. Once recommended, to minimize swallowing for children under 6,use a pea sized amount and supervise brushing until good habits are established.

Description

Active ingredient Sodium Fluoride (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 12 years of age and under. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide.

Section 51945-4

H-E-B®

DRY MOUTH

FLUORIDE ANTICAVITY TOOTHPASTE

Fresh Mint

NET WT. 4.3 OZ (122g)

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium Fluoride (0.15% w/v fluoride ion)


Structured Label Content

Indications and Usage (34067-9)

Use

  • aids in the prevention of dental cavities
Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and older: Apply onto a soft bristle toothbrush.

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician.

Children under 12 years of age: consult a dentist or physician. Once recommended, to minimize swallowing for children under 6,use a pea sized amount and supervise brushing until good habits are established.

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 12 years of age and under. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide.

Section 51945-4 (51945-4)

H-E-B®

DRY MOUTH

FLUORIDE ANTICAVITY TOOTHPASTE

Fresh Mint

NET WT. 4.3 OZ (122g)

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium Fluoride (0.15% w/v fluoride ion)


Advanced Ingredient Data


Raw Label Data

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