5820276 Nature's Promise Kids Fluoride Tp Strawberry

5820276 Nature's Promise Kids Fluoride Tp Strawberry
SPL v7
SPL
SPL Set ID 81a4e196-8b2d-0745-e053-2991aa0a7de6
Route
DENTAL
Published
Effective Date 2019-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.13 g)
Inactive Ingredients
Glycerin Carrageenan Calcium Carbonate Hydrated Silica Water Sodium Lauroyl Sarcosinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-11

Description

Active ingredient Sodium Monofluorophosphate 0.76% w/w (0.13% w/v fluoride ion)


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use

helps protect against cavities

Dosage and Administration

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

​Children under 2 years of age: consult a dentist or physician.

Description

Active ingredient Sodium Monofluorophosphate 0.76% w/w (0.13% w/v fluoride ion)

Section 42229-5

Drug Facts

Section 44425-7

Other information

Store in a cool dry place. Keep tube capped when not in use.

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauroyl sarcosinate

Section 51945-4

Nature's Promise

children's fluoride toothpaste

strawberry

  • protects against cavities
  • tastes great
  • helps fight tartar

NET WT 4.2 OZ (119 g)

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium Monofluorophosphate 0.76% w/w (0.13% w/v fluoride ion)


Structured Label Content

Indications and Usage (34067-9)

Use

helps protect against cavities

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

​Children under 2 years of age: consult a dentist or physician.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

Store in a cool dry place. Keep tube capped when not in use.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauroyl sarcosinate

Section 51945-4 (51945-4)

Nature's Promise

children's fluoride toothpaste

strawberry

  • protects against cavities
  • tastes great
  • helps fight tartar

NET WT 4.2 OZ (119 g)

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium Monofluorophosphate 0.76% w/w (0.13% w/v fluoride ion)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)