Label: IODENT MAXIMUM STRENGTH ORAL ANALGESIC - benzocaine gel
- NDC Code(s): 65923-010-11
- Packager: United Exchange Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
Active ingredient Purpose
Benzocaine 20%...............................................Oral pain relieverClose
Uses temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliancesClose
Warnings Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anestheticsClose
- DO NOT USE
Do not use
- more than directed
- for more than 7 days unless directed by a doctor/dentist
- STOP USE
Stop use and ask a 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
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right awayClose
- INDICATIONS & USAGE
- remove cap and cut tip of tube on score mark
- adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist.
- children under 12 years of age: should be supervised in the use of this product
- children under 2 years of age: ask a doctor/dentist
- STORAGE AND HANDLING
- store at 15° to 25°C (59° to 77°F)
- do not use if tube tip is cut prior to opening
- This preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted.
- Do not use continuously
- Lot No. and Exp Date: see box or see crimp of tube
- INACTIVE INGREDIENT
Inactive ingredients flavor mint, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitolClose
- DOSAGE & ADMINISTRATION
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703 USA
Made in KoreaClose
- INGREDIENTS AND APPEARANCE
IODENT MAXIMUM STRENGTH ORAL ANALGESIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-010 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-010-11 1 in 1 CARTON 1 11.9 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/31/2013 Labeler - United Exchange Corp (840130579)