FDA Label for Pain Relief

View Indications, Usage & Precautions

ACTIVE INGREDIENTS
PURPOSE
USES
WARNINGS
OTHER
DO NOT USE
WHEN USING THIS PRODUCT
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL - SAFETEC ORAL PAIN RELIEF CARTON LABEL
PRINCIPAL DISPLAY PANEL - SAFETEC ORAL PAIN RELIEF PACKET LABEL

Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Safetec Of America, Inc.. 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

Benzocaine 20% (w/w)

Purpose

Oral pain reliever

Uses

temporarily relieves pain caused by

toothache
dental work
minor irritation or injury of the mouth and gums
canker sores
gum sores
cheek bites
denture irritation

Warnings

For oral use only. Avoid contact with eyes.

Other

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 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 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 help right away.

Do Not Use

for teething
in children under 2 years of age

When Using This Product

Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

Otc - Keep Out Of Reach Of Children

Keep out of reach 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 and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.
children under 2 years of age: do not use

Other Information

Do not use if packet is torn, cut, or opened
Store at room temperature, 15° to 30°C (59° to 86°F)
Avoid contact with eyes

Inactive Ingredients

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Questions Or Comments?

1-800-456-7077

Principal Display Panel - Safetec Oral Pain Relief Carton Label

NDC 61010-800-1

Safetec

First Aid

Oral Pain Relief

Fast mouth sore relief for:

Canker Sores

Gum Pain

Toothache

Dental Work

Reorder No. 53117

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel - Safetec Oral Pain Relief Carton Label - saf0l 0002 01

Principal Display Panel - Safetec Oral Pain Relief Packet Label