outrageous orange anticavity - oft51 mrt

outrageous orange anticavity - oft51 mrt
SPL v3
SPL
SPL Set ID 19de1e71-ab94-415f-b66d-e5748dea8317
Route
dental
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.0014 g)
Inactive Ingredients
water glycerin carrageenan sodium lauryl sulfate hydrated silica benzyl alcohol calcium carbonate orange lemon juice mango juice orange juice pineapple juice strawberry juice

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2019-11-15

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients

glycerin, water, calcium carbonate, hydrated silica, benzyl alcohol, sodium lauryl sulfate, carrageenan, natural flavor, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Citrus aurantium dulcis (Orange) juice, Ananas sativus (Pineapple) fruit juice, Fragaria ananassa (Strawberry) fruit juice.

Description

Drug Facts

Questions?

1-800-FOR-TOMS (1-800-367-8667)

Use

helps protect against cavities

Section 42229-5

Drug Facts

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 dial (412) 390-3381 right away (Poison Control Center).

Active Ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Principal Display Panel 144 G Tube Label

ADA

Accepted

American

Dental

Association ®

THE ORIGINAL

Tom's

OF MAINE

Kid's

• NATURAL •

fluoride

anticavity toothpaste

fights cavities

tastes great • dye free

ages

2+

OUTRAGEOUS

ORANGE MANGO

NET WT

5.1 OZ

(144 g)

BRUSH

RECYCLE*

SMILE


Structured Label Content

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients (Inactive ingredients)

glycerin, water, calcium carbonate, hydrated silica, benzyl alcohol, sodium lauryl sulfate, carrageenan, natural flavor, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Citrus aurantium dulcis (Orange) juice, Ananas sativus (Pineapple) fruit juice, Fragaria ananassa (Strawberry) fruit juice.

Questions?

1-800-FOR-TOMS (1-800-367-8667)

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

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 dial (412) 390-3381 right away (Poison Control Center).

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Principal Display Panel 144 G Tube Label (PRINCIPAL DISPLAY PANEL - 144 g Tube Label)

ADA

Accepted

American

Dental

Association ®

THE ORIGINAL

Tom's

OF MAINE

Kid's

• NATURAL •

fluoride

anticavity toothpaste

fights cavities

tastes great • dye free

ages

2+

OUTRAGEOUS

ORANGE MANGO

NET WT

5.1 OZ

(144 g)

BRUSH

RECYCLE*

SMILE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)