SENSITIVE WHITENING WITH BAKING SODA- sodium fluoride paste, dentifrice

Sensitive by

Drug Labeling and Warnings

Sensitive 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 0.243%

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

Fluoride Anti-Cavity ToothpasteFrosted Mint Flavor

Sensitive From the Makers of

Orajel

Maximum Relief Without a Prescription

NET WT.

4.5 OZ. (127g) Whitening with Baking Soda

Carton image

INGREDIENTS AND APPEARANCE

SENSITIVE  WHITENING WITH BAKING SODA
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-660
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 SODIUM (UNII: SB8ZUX40TY)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-660-45	1 in 1 CARTON	05/01/2012	09/30/2019
1		127 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-660-09	1 in 1 CARTON	05/01/2012	09/30/2019
2		25 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	01/29/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-660)