SPL v4
SPL
SPL Set ID d9068a54-6123-4715-b025-a5bdb4d5c702
Route
TOPICAL
Published
Effective Date 2014-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 3350 Peppermint Oil Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-06

Description

Drug Facts Dental Relief

Purpose

Oral antiseptic


Medication Information

Purpose

Oral antiseptic

Description

Drug Facts Dental Relief

Uses

For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Section 42229-5

Drug Facts

Dental Relief

Warnings

For oral use only

Directions
  • Adults and children 2 years 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
  • Consult a dentist or doctor for use on children under 2 years of age
  • Children under 12 years of should be supervised in the use of this product
Allergy Alert

Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock.

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
Active Ingredients

Benzocaine 20% (w/w)

Inactive Ingredients

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

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.

Keep Out of Reach of Children.

If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel – Pocket Card

Dental Relief

PROFESSIONAL STRENGTH

RELIEVES DENTAL PAIN

COMPARE TO ORAJEL

SEE DRUG FACTS CARD

FOR COMPLETE WARNINGS

560718

12/13

Xpect

First aid

Principal Display Panel – 0.5 Gram Packet

Dental Relief

Active ingredients: Benzocaine (20%), Compound benzoin tincture

USES: Temporarily relieves pain due to canker sores, minor irritation of

the mouth and gums caused by dentures or orthodontic appliances,

or minor mouth and gum injuries.

Do not use if packet is torn or broken

NET WT 0.5g


Structured Label Content

Uses

For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Section 42229-5 (42229-5)

Drug Facts

Dental Relief

Purpose

Oral antiseptic

Warnings

For oral use only

Directions
  • Adults and children 2 years 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
  • Consult a dentist or doctor for use on children under 2 years of age
  • Children under 12 years of should be supervised in the use of this product
Allergy Alert (Allergy alert)

Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock.

Other Information (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
Active Ingredients

Benzocaine 20% (w/w)

Inactive Ingredients

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

When Using This Product (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel – Pocket Card

Dental Relief

PROFESSIONAL STRENGTH

RELIEVES DENTAL PAIN

COMPARE TO ORAJEL

SEE DRUG FACTS CARD

FOR COMPLETE WARNINGS

560718

12/13

Xpect

First aid

Principal Display Panel – 0.5 Gram Packet (Principal Display Panel – 0.5 gram Packet)

Dental Relief

Active ingredients: Benzocaine (20%), Compound benzoin tincture

USES: Temporarily relieves pain due to canker sores, minor irritation of

the mouth and gums caused by dentures or orthodontic appliances,

or minor mouth and gum injuries.

Do not use if packet is torn or broken

NET WT 0.5g


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