73928-051-01 Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash

73928-051-01 Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash
SPL v1
SPL
SPL Set ID 3de0d71a-7704-97dd-e063-6294a90a5d2c
Route
ORAL
Published
Effective Date 2024-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.05 g)
Inactive Ingredients
Polyoxyl 40 Hydrogenated Castor Oil Cetylpyridinium Chloride Sucralose Saccharin Sodium Citric Acid Monohydrate Fd&c Red No. 40 Sorbitol Methyl Diisopropyl Propionamide Water Potassium Sorbate Glycerin Xylitol D&c Red No. 33 Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

SODIUM FLUORIDE 0.05%

Purpose

(0.02% w/v fluoride ion)----Anticavity


Medication Information

Warnings and Precautions

Keep out of reach of children under 6 years of age, lf youaccidentally swallow more than used for rinsing, seek professionahelp or contact a Poison Control Center immediately.

Purpose

(0.02% w/v fluoride ion)----Anticavity

Description

SODIUM FLUORIDE 0.05%

Uses

helps protect teeth against cavities.

Section 51945-4

Warnings

Keep out of reach of children under 6 years of age.lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children 6 years and older:

  • Use daily after you brush your teeth with toothpaste
  • Rinse toothpaste from mouth prior to use.
  • Shake well before each use.
  • Twist and remove cap.
  • Rinse or gargle for 30 seconds with 15 ml and spit out
  • Do Not swallow the rinse.
  • Do Not eat or drink for 30 minutes after rinsing Supervise children as necessary.
  • Children under 6 years of age, consult with a dentist or doctor.
Active Ingredient

SODIUM FLUORIDE 0.05%

Inactive Ingredients

Water

SORBITOL

GLYCERIN

XYLITOL

SODIUM BENZOATE

POTASSIUM SORBATE

PEG-40 HYDROGENATED CASTOR OIL

MENTHA HAPLOCALYX OIL

SODIUM SACCHARIN

CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE

CITRIC ACID


Structured Label Content

Uses

helps protect teeth against cavities.

Warnings and Precautions (34071-1)

Keep out of reach of children under 6 years of age, lf youaccidentally swallow more than used for rinsing, seek professionahelp or contact a Poison Control Center immediately.

Section 51945-4 (51945-4)

Purpose

(0.02% w/v fluoride ion)----Anticavity

Warnings

Keep out of reach of children under 6 years of age.lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children 6 years and older:

  • Use daily after you brush your teeth with toothpaste
  • Rinse toothpaste from mouth prior to use.
  • Shake well before each use.
  • Twist and remove cap.
  • Rinse or gargle for 30 seconds with 15 ml and spit out
  • Do Not swallow the rinse.
  • Do Not eat or drink for 30 minutes after rinsing Supervise children as necessary.
  • Children under 6 years of age, consult with a dentist or doctor.
Active Ingredient (Active ingredient)

SODIUM FLUORIDE 0.05%

Inactive Ingredients (Inactive ingredients)

Water

SORBITOL

GLYCERIN

XYLITOL

SODIUM BENZOATE

POTASSIUM SORBATE

PEG-40 HYDROGENATED CASTOR OIL

MENTHA HAPLOCALYX OIL

SODIUM SACCHARIN

CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE

CITRIC ACID


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)