colgate®

colgate®
SPL v2
SPL
SPL Set ID 1a3026a6-bc34-4dfe-bdf7-84e1ef43480c
Route
dental
Published
Effective Date 2020-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (2.4 mg) nitrate ion (50 mg)
Inactive Ingredients
water glycerin hydrated silica sorbitol polyethylene glycol 600 butyl ester of methyl vinyl ether/maleic anhydride copolymer (125000 mw) sodium phosphate, tribasic, anhydrous sodium lauryl sulfate poloxamer 407 sodium hydroxide saccharin sodium carboxymethylcellulose sodium, unspecified xanthan gum titanium dioxide fd&c blue no. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph drug active Since 2020-10-16

Description

Drug Facts


Medication Information

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities
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 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 years consult a dentist or physician
Inactive Ingredients

Water, Glycerin, Hydrated Silica, Sorbitol, PEG-12, PVM/MA Copolymer, Sodium Lauryl Sulfate, Flavor, Trisodium Phosphate, Poloxamer 407, Sodium Hydroxide, Sodium Saccharin, Cellulose Gum, Xanthan Gum, Blue 1.

Description

Drug Facts

Questions?

1-800-468-6502

Section 42229-5

Drug Facts

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

Stop use and ask a 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, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Section 55105-1
Active ingredients Purpose
Potassium Nitrate 5% Antisensitivity
Sodium Fluoride 0.24% (0.14% w/v fluoride ion) Anticavity
Principal Display Panel 60 G Tube Carton

Colgate®

Anticavity Toothpaste for Sensitive Teeth

ULTRA

RELIEF

Relieves tooth sensitivity + Strengthens enamel

gel

NET WT 2.1 OZ (60 g)


Structured Label Content

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities
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 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 years consult a dentist or physician
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Hydrated Silica, Sorbitol, PEG-12, PVM/MA Copolymer, Sodium Lauryl Sulfate, Flavor, Trisodium Phosphate, Poloxamer 407, Sodium Hydroxide, Sodium Saccharin, Cellulose Gum, Xanthan Gum, Blue 1.

Questions?

1-800-468-6502

Section 42229-5 (42229-5)

Drug Facts

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)

Stop use and ask a 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, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Section 55105-1 (55105-1)
Active ingredients Purpose
Potassium Nitrate 5% Antisensitivity
Sodium Fluoride 0.24% (0.14% w/v fluoride ion) Anticavity
Principal Display Panel 60 G Tube Carton (PRINCIPAL DISPLAY PANEL - 60 g Tube Carton)

Colgate®

Anticavity Toothpaste for Sensitive Teeth

ULTRA

RELIEF

Relieves tooth sensitivity + Strengthens enamel

gel

NET WT 2.1 OZ (60 g)


Advanced Ingredient Data


Raw Label Data

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