24/7 Life Oral Pain Relief Gel 0.5 Oz (58853a)

24/7 Life Oral Pain Relief Gel 0.5 Oz (58853a)
SPL v9
SPL
SPL Set ID f170a570-1c50-4b9a-be16-9b01bf5eaa74
Route
TOPICAL
Published
Effective Date 2016-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 4000 Saccharin Sodium Sorbitol Glycerin Mint

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-08

Description

Active ingredient                                 Purpose Benzocaine 20%.................................Oral Pain reliever


Medication Information

Warnings and Precautions

Warnings

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 meddical 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

Indications and Usage

Directions

Adults and children 2 years of age and older. Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or dentist.
Children under 12 years of age. Should be supervised in the use of this product.
Children under 2 years of age. Do not use.

Dosage and Administration

DISTRIBUTED BY 7-ELEVEN, INC.

Irving, TX 75063

WWW.7-ELEVEN.COM

Description

Active ingredient                                 Purpose Benzocaine 20%.................................Oral Pain reliever

Section 44425-7

Other information

  • store at 20° to 25°C (68° to 77°F)
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted
  • do not use continuously
Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Section 50570-1

Do not use

  • more than directed
  • for more than 7 days unless directed by a dentist or doctor
  • for teething
  • in children under 2 years of age
Section 51727-6

Inactive ingredients glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Use for the temporary relief of pain due to:

  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites
Section 55106-9

Active ingredient                                 Purpose

Benzocaine 20%.................................Oral Pain reliever


Structured Label Content

Indications and Usage (34067-9)

Directions

Adults and children 2 years of age and older. Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or dentist.
Children under 12 years of age. Should be supervised in the use of this product.
Children under 2 years of age. Do not use.

Dosage and Administration (34068-7)

DISTRIBUTED BY 7-ELEVEN, INC.

Irving, TX 75063

WWW.7-ELEVEN.COM

Warnings and Precautions (34071-1)

Warnings

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 meddical 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

Section 44425-7 (44425-7)

Other information

  • store at 20° to 25°C (68° to 77°F)
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted
  • do not use continuously
Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Section 50570-1 (50570-1)

Do not use

  • more than directed
  • for more than 7 days unless directed by a dentist or doctor
  • for teething
  • in children under 2 years of age
Section 51727-6 (51727-6)

Inactive ingredients glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Use for the temporary relief of pain due to:

  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites
Section 55106-9 (55106-9)

Active ingredient                                 Purpose

Benzocaine 20%.................................Oral Pain reliever


Advanced Ingredient Data


Raw Label Data

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