SPL v1
SPL
SPL Set ID 352342bf-e2dd-3a2c-e063-6294a90a200e
Route
ORAL
Published
Effective Date 2025-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.05 g)
Inactive Ingredients
Peg-40 Hydrogenated Castor Oil Sodium Bicarbonate Xylitol Methylparaben Glycerin Sodium Lauryl Sulfate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-05-01

Description

Active ingredient(s) Allantoin 0.05%


Medication Information

Warnings and Precautions

Warnings

■ For oral use only; do not swallow.

■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

■ Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

■ Stop use and ask a dentist if • Gingivitis, bleeding, or redness persists for more than 2 weeks. • You have painful of swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious from of gum disease.

■ If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

Use(s)

■ Aids in the prevention of dental cavities.

■ Helps remove plaque that leads to gingivitis, an early form of gum disease.

■ Helps protect the mouth against everyday irritants

■ Freshens breath while protecting oral tissues

■ Helps soothe and protect irritated gums and mouth

Dosage and Administration

Directions

■ Dispense foam directly into mouth • Swish thoroughly for 30 seconds to 1 minute, and then spit out. Do not swallow the rinse • Use 2–3 times daily or as directed by a dentist or doctor.

Description

Active ingredient(s) Allantoin 0.05%

Section 51727-6

Inactive ingredients

Water, Glycerin, Xylitol, Steviol glucoside, Sodium Lauryl Sulfate, Sodium Bicarbonate, Methylparaben, Polyoxyl 40 Hydrogenated Caster Oil, Flavor, Menthol, Glycyrrhiza Uralensis (Licorice) Extract, Punica Granatum Fruit Extract, Rosmarinus Officinalis (Rosemary) Extract, Chamomilla Recutita (Matricaria) Extract, Propolis Extract, Camellia Sinensis (Green Tea) Leaf Extract

Section 51945-4

Section 53413-1

Questions

■ www.foamgle.com

Section 55105-1

Purpose

Oral Tissue protectant, alleviation of oral irritation

Section 55106-9

Active ingredient(s)

Allantoin 0.05%

Section 60561-8

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

■ Store at 15°–30°C (59°–86°F)

■ Do not freeze.


Structured Label Content

Indications and Usage (34067-9)

Use(s)

■ Aids in the prevention of dental cavities.

■ Helps remove plaque that leads to gingivitis, an early form of gum disease.

■ Helps protect the mouth against everyday irritants

■ Freshens breath while protecting oral tissues

■ Helps soothe and protect irritated gums and mouth

Dosage and Administration (34068-7)

Directions

■ Dispense foam directly into mouth • Swish thoroughly for 30 seconds to 1 minute, and then spit out. Do not swallow the rinse • Use 2–3 times daily or as directed by a dentist or doctor.

Warnings and Precautions (34071-1)

Warnings

■ For oral use only; do not swallow.

■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

■ Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

■ Stop use and ask a dentist if • Gingivitis, bleeding, or redness persists for more than 2 weeks. • You have painful of swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious from of gum disease.

■ If pregnant or breast-feeding, ask a health professional before use.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Glycerin, Xylitol, Steviol glucoside, Sodium Lauryl Sulfate, Sodium Bicarbonate, Methylparaben, Polyoxyl 40 Hydrogenated Caster Oil, Flavor, Menthol, Glycyrrhiza Uralensis (Licorice) Extract, Punica Granatum Fruit Extract, Rosmarinus Officinalis (Rosemary) Extract, Chamomilla Recutita (Matricaria) Extract, Propolis Extract, Camellia Sinensis (Green Tea) Leaf Extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

■ www.foamgle.com

Section 55105-1 (55105-1)

Purpose

Oral Tissue protectant, alleviation of oral irritation

Section 55106-9 (55106-9)

Active ingredient(s)

Allantoin 0.05%

Section 60561-8 (60561-8)

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

■ Store at 15°–30°C (59°–86°F)

■ Do not freeze.


Advanced Ingredient Data


Raw Label Data

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