OTC Medication Information: SENSITIVE ANTI-CAVITY

SENSITIVE ANTI-CAVITY- potassium nitrate and sodium fluoride paste
Universal Distribution Center LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Potassium Nitrate 5%

Sodium Fluoride (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • aids in the prevention of dental cavities.

Warning

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children

  • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and Children 12 years of age and older:

  • apply at least a 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor.
  • make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

Children under 12 years of age: Consult a dentist or doctor.

Other information

  • store in a cool, dry place.

Inactive Ingredients

D&C yellow#10, FD&C blue#1, flavor, glycerin, methylparaben, poly ethylene glycol 1500, propylparaben, silica, sodium benzoate, sodium carboxy methyl cellulose, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, treated water, tri sodium ortho phosphate.

PRINCIPAL DISPLAY PANEL

SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

label
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SENSITIVE ANTI-CAVITY
potassium nitrate and sodium fluoride paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-037
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 50 mg in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GLYCERIN
METHYLPARABEN
POLYETHYLENE GLYCOL 1500
PROPYLPARABEN
SILICON DIOXIDE
SODIUM BENZOATE
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
SACCHARIN SODIUM
SORBITOL
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52000-037-47 1 TUBE in 1 BOX contains a TUBE
1 122 g in 1 TUBE This package is contained within the BOX (52000-037-47)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/21/2017
Labeler — Universal Distribution Center LLC (019180459)
Registrant — Universal Distribution Center LLC (019180459)
Establishment
Name Address ID/FEI Operations
Yangzhou Holyshine Industrial Co. Ltd 421141948 manufacture (52000-037)

Revised: 06/2017 Universal Distribution Center LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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