IODENT ORAL ANALGESIC- benzocaine gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Available from:
United Exchange Corp.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses for the temporary relief of pain due to: - toothache - canker sores - gum pain - denture pain - cheek bites 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 Directions
Authorization status:
OTC monograph not final
Authorization number:
65923-094-11

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 2020)

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

IODENT ORAL ANALGESIC

benzocaine gel

United Exchange Corp.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 59 23-0 9 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

20 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

PO LYETHYLENE GLYCO L 4 0 0 0 (UNII: 4R4HFI6 D9 5)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 59 23-0 9 4-11

1 in 1 CARTON

0 1/0 2/20 18

1

11.9 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 1/0 2/20 18

Labeler -

United Exchange Corp. (840130579)

Revised: 3/2020

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