SENSITIVE TEETH AND GUMS- potassium nitrate, sodium fluoride paste, dentifrice

Sensitive Teeth and Gums by

Drug Labeling and Warnings

Sensitive Teeth and Gums by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Potassium nitrate 5.0%

Sodium fluoride 0.24%

PURPOSE

Purpose

Antihypersensitivity

Anticavity toothpaste

INDICATIONS & USAGE

Use 

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

      

WARNINGS

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of 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 right away.

DOSAGE & ADMINISTRATION

Directions    do not swallow   

adults and children 12 years and older

• apply at least a 1-inch strip of the product onto a soft bristly toothbrush. Brush teeth for at least one minute, preferable after each meal or at least 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 INGREDIENT

Inactive ingredients   sodium bicarbonate (baking soda), water, sorbitol, glycerin, hydrated silica, flavor, sodium saccharin, sodium lauroyl sarcosinate, sodium lauryl sulfate, cellulose gum, titanium dioxide, xanthan gum

QUESTIONS

Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET or visit www.myoralcare.com

Principal Display Panel

ARM AND HAMMER The Standard of Purity

Refreshing Mint Naturally Powered By Baking Soda Fluoride Anticavity Toothpaste for Sensitive Teeth

Sensitive Teeth and Gums

NET WT.

4.5 OZ. (127g) Gentle Whitening Strengthens Enamel Low Abrasion From the Maker of Orajel

INGREDIENTS AND APPEARANCE

SENSITIVE TEETH AND GUMS 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-669
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.43 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SACCHARIN (UNII: FST467XS7D)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT (Refreshing Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-669-45	1 in 1 CARTON	10/16/2017
1		127 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/16/2017

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-669)