Arm and Hammer Sensitive Freshening Toothpaste

Drug Labeling and Warnings

Drug Details [pdf]

ARM AND HAMMER ORAJEL SENSITIVE FRESHENING WITH FLAVOR BURST- sodium fluoride paste, dentifrice 
Church & Dwight Co., Inc.

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.

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Arm and Hammer Sensitive Freshening Toothpaste

Active ingredients        
Potassium nitrate 5.0%
Sodium fluoride 0.243%

Purpose

Antihypersensitivity
Anticavity toothpaste

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

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 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 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 ANTICAVITY TOOTHPASTE FROSTED MINT FLAVOR

Sensitive From the Makers of Orajel

Maximum Relief Without a Prescription

Freshening with Flavor Burst

NET WT.

4.5 OZ. (127g)

ARM AND HAMMER ORAJEL SENSITIVE  FRESHENING WITH FLAVOR BURST
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-661
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 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: 10237-661-45	1 in 1 CARTON	01/29/2012	10/28/2019
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	01/29/2012	10/28/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-661)

Revised: 10/2019

Document Id: 95fe3aa6-664a-64bf-e053-2995a90ab91c

34390-5

Set id: 8cbea492-9a20-43c8-a90c-692159a1dcae

Version: 6

Effective Time: 20191028