5820111 Care One Max Str Sensitive Extra Whitening

5820111 Care One Max Str Sensitive Extra Whitening
SPL v10
SPL
SPL Set ID 24715cc7-cf02-4ea0-a491-2a111ad3660e
Route
DENTAL
Published
Effective Date 2014-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g) Nitrate Ion (5 g)
Inactive Ingredients
Water Saccharin Sodium Sodium Tripolyphosphate Polyethylene Glycol 400 Sorbitol Titanium Dioxide Sodium Hydroxide Glycerin Xanthan Gum Hydrated Silica Cocamidopropyl Betaine Sodium Methyl Cocoyl Taurate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-01-20
Description

Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention oif dental cavities
Dosage and Administration

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: consult a dentist or physician.
Description

Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Section 42229-5

DISTRIBUTED BY:

American Sales Company

4201 Walden Avenue

Lancaster, NY 14086

Section 44425-7

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

Section 50565-1

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

Section 50566-9

See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

Section 51727-6

Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

Section 51945-4

Section 55105-1

Purpose

Antihypersensitivity

Anticavity

Section 55106-9

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention oif dental cavities
Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: consult a dentist or physician.
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DISTRIBUTED BY:

American Sales Company

4201 Walden Avenue

Lancaster, NY 14086

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7 (50567-7)

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

Section 51727-6 (51727-6)

Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:14.483115 · Updated: 2026-03-14T23:10:29.645873