brush buddies crayola anticavity fluoride watermelon(0.03%)

brush buddies crayola anticavity fluoride watermelon(0.03%)
SPL v22
SPL
SPL Set ID 188cddb2-c799-0897-e063-6294a90a5d96
Route
oral
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.03 g)
Inactive Ingredients
sorbitol sodium benzoate citric acid monohydrate polyoxyl 40 hydrogenated castor oil sucralose methyl diisopropyl propionamide potassium sorbate glycerin xylitol saccharin sodium water cetylpyridinium chloride fd&c yellow no. 5 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-01

Purpose

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

Description

SODIUM FLUORIDE 0.03%


Medication Information

Warnings and Precautions

Keep out of reac 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 Notswallow the rinse.
  • Do Noteat 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

FLAVOR

SODIUM SACCHARIN

CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE

CITRIC ACID

FD&C Yellow No.5(CI 19140)

FD&C Blue No.1(CI 42090)

Description

SODIUM FLUORIDE 0.03%

Section 51945-4

Active Ingredient

SODIUM FLUORIDE 0.03%


Structured Label Content

Warnings and Precautions (34071-1)

Keep out of reac 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 (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 Notswallow the rinse.
  • Do Noteat 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

FLAVOR

SODIUM SACCHARIN

CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE

CITRIC ACID

FD&C Yellow No.5(CI 19140)

FD&C Blue No.1(CI 42090)

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

SODIUM FLUORIDE 0.03%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)