Iodent Oral Analgesic Gel 0.42 oz 490 (ZDP 2019)

Iodent Oral Analgesic Gel 0.42 oz 490 (ZDP 2019)

Drug Labeling and Warnings

Drug Details

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IODENT ORAL ANALGESIC- benzocaine gel 
United Exchange Corp.

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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Iodent Oral Analgesic Gel 0.42 oz 490 (ZDP 2019)

Active ingredient Purpose

Benzocaine 20%............................................Oral Pain Reliever

Uses

for the temporary relief of pain due to:

  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy Alert: do not use this product if your child has a history of allergy or local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor
  • for teething
  • in children under 2 years of age

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness does not go away
  • swelling, rash or fever develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 2 years of age and older.Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. 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.Do not use.

Other information

  • store at room temperature 20° to 25°C (68° to 77°)
  • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist or doctor can be consulted
  • do not use continuously

Inactive ingredients

glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

1-800-814-8028

Made in China

490.1

IODENT ORAL ANALGESIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65923-094
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65923-094-111 in 1 CARTON01/02/2018
111.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/02/2018
Labeler - United Exchange Corp. (840130579)

Revised: 5/2019
 
United Exchange Corp.


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