268a5cc3-b688-490d-b64c-9cb51fe7560d

SPL v1
SPL
SPL Set ID 268a5cc3-b688-490d-b64c-9cb51fe7560d
Route
oral
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 g)
Inactive Ingredients
water sorbitol carbomer homopolymer type c (allyl pentaerythritol crosslinked) sodium lauryl sulfate sodium hydroxide sodium saccharin sodium benzoate edetate disodium menthol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-01
Purpose

Anticavity Toothpaste

Description

Sodium Fluoride 0.22 % ( 0.1 % W/V Fluoride Ion)

Medication Information

Warnings

• Keep out of the 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 immediately

Uses

• Help Protect against cavities

Purpose

Anticavity Toothpaste

Directions
 Adults & children 6 years of age & older:  Brush teeth thoroughly, Preferably after each meal of at least twice a day, or as directed by a dentist or doctor
 Children 2 to 6 years  Use only pea sized amount and supervise child’s brushing and rinsing (to minimize swallowing).
 Children under 2 years  Ask a dentist or physician

Inactive Ingredients

Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium saccharin, Sodium Benzoate, Disodium EDTA, Menthol

Description

Sodium Fluoride 0.22 % ( 0.1 % W/V Fluoride Ion)

Section 50565-1

Product Label

Active Ingredient

Sodium Fluoride 0.22 % ( 0.1 % W/V Fluoride Ion)

Structured Label Content

Warnings

• Keep out of the 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 immediately

Uses

• Help Protect against cavities

Purpose

Anticavity Toothpaste

Directions
 Adults & children 6 years of age & older:  Brush teeth thoroughly, Preferably after each meal of at least twice a day, or as directed by a dentist or doctor
 Children 2 to 6 years  Use only 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)

Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium saccharin, Sodium Benzoate, Disodium EDTA, Menthol

Section 50565-1 (50565-1)

Product Label (Product label)

Active Ingredient

Sodium Fluoride 0.22 % ( 0.1 % W/V Fluoride Ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:51.471655 · Updated: 2026-03-14T23:09:51.959406