IODENT ORAL ANALGESIC- benzocaine gel

Iodent Oral Analgesic by

Drug Labeling and Warnings

Iodent Oral Analgesic by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

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

PURPOSE

Uses

for the temporary relief of pain due to:

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

WARNINGS

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

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

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

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

INDICATIONS & USAGE

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.

STORAGE AND HANDLING

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 INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

1-800-814-8028

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IODENT ORAL ANALGESIC 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-094
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-094-11	1 in 1 CARTON	01/02/2018
1		11.9 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	01/02/2018

Labeler - United Exchange Corp. (840130579)