Close Up Freshening Gel

Close Up Freshening Gel
SPL v11
SPL
SPL Set ID e660b0d7-4cc5-4028-bdf5-016b85899728
Route
DENTAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg)
Inactive Ingredients
Water Hydrated Silica Peg-8 Stearate Sorbitol Sodium Lauryl Sulfate Alcohol Carboxymethylcellulose Sodium, Unspecified D&c Red No. 33 Fd&c Red No. 40 Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2001-03-01 Until 2022-05-25

Description

Active ingredients Sodium fluoride (0.24%)


Medication Information

Warnings and Precautions

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Use:Aids in the prevention of dental decay

Dosage and Administration

Directions   do not swallow    supervise children as necessary until capable of using without supervision

adults and children 2 years and older               brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

children under 6 years                                    instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years                                    ask a dentist or physician

Description

Active ingredients Sodium fluoride (0.24%)

Section 50565-1

Warnings

Keep out of reach of children under 6 years of age
.

Section 51727-6

Inactive ingredients  sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, red 33, red 40.

Section 53413-1

Questions or comments?  Call 1-800-786-5135Monday-Friday 9am-5pm ET

Section 55105-1

Purpose

Anticavity toothpaste

Section 55106-9

Active ingredients

Sodium fluoride (0.24%)

Principal Display Panel

ANITCAVITY FLOURIDE TOOTHPASTE

FRESH BREATH

Fights bad breath while gently whitening

CLOSE-UP

CINNAMON BLAST

NET WT. 4.0 OZ. (113g)


Structured Label Content

Indications and Usage (34067-9)

Use:Aids in the prevention of dental decay

Dosage and Administration (34068-7)

Directions   do not swallow    supervise children as necessary until capable of using without supervision

adults and children 2 years and older               brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

children under 6 years                                    instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years                                    ask a dentist or physician

Warnings and Precautions (34071-1)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Warnings

Keep out of reach of children under 6 years of age
.

Section 51727-6 (51727-6)

Inactive ingredients  sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, red 33, red 40.

Section 53413-1 (53413-1)

Questions or comments?  Call 1-800-786-5135Monday-Friday 9am-5pm ET

Section 55105-1 (55105-1)

Purpose

Anticavity toothpaste

Section 55106-9 (55106-9)

Active ingredients

Sodium fluoride (0.24%)

Principal Display Panel

ANITCAVITY FLOURIDE TOOTHPASTE

FRESH BREATH

Fights bad breath while gently whitening

CLOSE-UP

CINNAMON BLAST

NET WT. 4.0 OZ. (113g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)