61010-8100-1,-2, Pain Relief

61010-8100-1,-2, Pain Relief
SPL v4
SPL
SPL Set ID de84e598-d047-4fae-b2ed-155a3788bc6f
Route
TOPICAL
Published
Effective Date 2018-12-04
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 DRUG Active Since 2010-05-01

Description

Benzocaine 20% (w/w)

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Benzocaine 20% (w/w)

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
Section 42229-5

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
Section 50565-1

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

Warnings

For oral use only.Avoid contact with eyes.

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
Do Not Use
  • for teething
  • in children under 2 years of age
Other Information
  • Do not use if packet is torn, cut, or opened
  • Store at room temperature, 15º to 30ºC (59º to 86ºF)
  • Avoid contact with eyes
Active Ingredients

Benzocaine 20% (w/w)

Inactive Ingredients

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

Questions Or Comments?

1-800-456-7077

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.

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 Packet Label

Safetec

Oral Pain Relief

0.75 g (1/38 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077


Structured Label Content

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
Section 42229-5 (42229-5)

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
Section 50565-1 (50565-1)

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

Purpose

Oral pain reliever

Warnings

For oral use only.Avoid contact with eyes.

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
Do Not Use (Do not use)
  • for teething
  • in children under 2 years of age
Other Information
  • Do not use if packet is torn, cut, or opened
  • Store at room temperature, 15º to 30ºC (59º to 86ºF)
  • Avoid contact with eyes
Active Ingredients

Benzocaine 20% (w/w)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or Comments?)

1-800-456-7077

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.

Principal Display Panel Safetec Oral Pain Relief Carton Label (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 Packet Label (Principal Display Panel - Safetec Oral Pain Relief Packet Label)

Safetec

Oral Pain Relief

0.75 g (1/38 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077


Advanced Ingredient Data


Raw Label Data

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