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

Purpose

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

Description

SODIUM FLUORIDE 0.05%


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.

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.

Uses

helps protect teeth against cavities.

Purpose

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

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.
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

Description

SODIUM FLUORIDE 0.05%

Section 51945-4

Active Ingredient

SODIUM FLUORIDE 0.05%


Structured Label Content

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.

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.

Uses

helps protect teeth against cavities.

Purpose

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

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.
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

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

SODIUM FLUORIDE 0.05%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)