FDA Label for Dentarin

View Indications, Usage & Precautions

ACTIVE INGREDIENTS:
USES:
WARNINGS: METHEMOGLOBINEMIA WARNING:
ALLERGY ALERT
FLAMMABILITY WARNING
DO NOT USE
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREASTFEEDING
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS:
OTHER INFORMATION
INACTIVE INGREDIENTS
CHANGE IN SECTION TYPE:
DOSEAGE AND ADMINISTRATION
DENTARIN

Dentarin Product Label

The following document was submitted to the FDA by the labeler of this product Vitamex Usa, Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:

Active Ingredients: Purpose

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

Uses:

Uses: Temporarily relieves pain caused by toothache, canker, sores, cold sores, fever blisters, minor irritation or injury of the moth and gums.

Warnings: Methemoglobinemia Warning:

Warnings: Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condiiton tha tmust 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 pal, gray, or blue colored skin cyanosis), headache, rapid heartbeat, shortness of breath, diziness or lightheadedness, fatigue or lack of enerygy. Keep away from eyes.

Allergy Alert

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" anesthetics. If a skin reaction occurs, stop use and seek medical attention right away.

Flammability Warning

Flammability warning: keep away from fire or flame

Do Not Use

Do not use: more than directed, for more than 7 days unless told to do so by a dentist or doctor, for teething, in children under 2 years of age.

Stop Use And Ask A Doctor If

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

If Pregnant Or Breastfeeding

If pregnant or breastfeeding, ask a health professional before use

Keep Out Of Reach Of Children

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

Directions:

Adults and children 2 years of age older \| Apply to affected area up to 4 times daily or as directed by 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

Directions: Spray a small amount of product around the affected area up to 4 times daily.

Other Information

Other information: Store at controlled room temperature: 15-30°C (59-86°F). Tamper Evident Feature: Do not use if cello-band over cap is torn, broken or missing.

Inactive Ingredients

Inactive ingredients: alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium methylparaben, sodium saccharin

Change In Section Type:

Change in section type from directions to indications and useage

Doseage And Administration

Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by 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