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DenTek Instant Pain Relief Maximum Strength

Medically reviewed on August 26, 2016

Dosage form: liquid
Ingredients: BENZOCAINE 200mg in 1mL
Labeler: Team Technologies, Inc
NDC Code: 67659-410

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.

DenTek Instant Pain Relief

Active ingredients

Benzocaine 20%

Purpose

Oral Pain Reliever

Use for the temporary relief of pain due to: . toothaches . canker sore . cold sores . sore gums

Warnings

Allergy alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

When using this product . avoid contact with the eyes . do not exceed recommended dosage . do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a dentist or doctor if. swelling, rash or fever develops . irritation, pain or redness persists or worsens . symptoms do not improve in 7 days

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions. dip applicator into liquid

Adults and children 2 years of age and older: Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.

Children under 12 years of age: Should be supervised in the use of this product.

Children under 2 years of age: Ask a dentist or doctor.

Other information . do not use if safety seal on carton is broken. . this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. . do not use continuously

Inactive ingredients: Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

Questions or comments? Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at info@DenTek.com

DenTek Instant Pain Relief Inner Vial Label

DenTek Instant Pain Relief Outer Carton Label

DENTEK INSTANT PAIN RELIEF  MAXIMUM STRENGTH
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-410(NDC:60630-077)
Route of AdministrationTOPICAL, DENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE10 mg  in 1 mL
PEPPERMINT OIL2.2 mg  in 1 mL
SPEARMINT OIL3.3 mg  in 1 mL
POLYETHYLENE GLYCOL 400784.5 mg  in 1 mL
Product Characteristics
Coloryellow (colorless to light yellow liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67659-410-221 VIAL, GLASS in 1 CARTON
1NDC:67659-410-203.5 mL in 1 VIAL, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/31/2015
Labeler - Team Technologies, Inc (192339703)
Registrant - Team Technologies, Inc (192339703)
Establishment
NameAddressID/FEIOperations
Team Technologies, Inc079527756relabel(67659-410), repack(67659-410)

 
Team Technologies, Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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