Orajel For Cold Sores Double Medicated, Cream

Orajel For Cold Sores Double Medicated, Cream
SPL v5
SPL
SPL Set ID b8699a40-8464-ca02-e053-2995a90a4260
Route
TOPICAL
Published
Effective Date 2021-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg) Petrolatum (736.4 mg)
Inactive Ingredients
Cholecalciferol Methylparaben Mineral Oil Polyethylene Glycol, Unspecified Prunella Vulgaris Flowering Top Vitamin A Palmitate .alpha.-tocopherol .alpha.-tocopherol Acetate, D- Water Corn Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-18

Description

Benzocaine 20% White petrolatum 73.64%


Medication Information

Warnings and Precautions

Warnings

For external use only

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 medical 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

Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

Dosage and Administration

Directions

  • cut open tube of tip on score mark
  • Do not use if tip is cut prior to opening

Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

Children betweem 2 and 12 years of age: Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age: Do not use

Description

Benzocaine 20% White petrolatum 73.64%

Section 50565-1

Keep out of reach of children.

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

Section 50570-1

Do not use

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

Inactive ingredients cholecalciferol, mineral oil, phenoxyethanol (and) hydroxyacetophenone (and) caprylyl glycol (and) water, propylene glycol, prunella vulgaris leaf extract, retinyl palmitate (vitamin A palmitate), tocopherol, tocopherol acetate (vitamin E acetate), zea mays (corn) oil

Section 51945-4

#1

ORAL PAIN

RELIVER

BRAND

FOR ADULTS

2 Active

Ingredients

Orajel

Instant Pain Relief

FOR COLD SORES

Fast-Acting Cream

DOUBLE MEDICATED

Relieves Pain & Itching

Moisturizing Barrier Stays in Place

Paraben Free

TOPICAL ANESTHETIC/SKIN PROTECTANT

NET WT 0.125 OZ (3.5 g)

Section 53413-1

Questions or comments?call us at 1-800-952-5080M-F 9am-5pm or visit our website at www.orajel.com

Section 55105-1

Topical anesthetic

Skin protectant

Section 55106-9

Benzocaine 20%

White petrolatum 73.64%


Structured Label Content

Indications and Usage (34067-9)

Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

Dosage and Administration (34068-7)

Directions

  • cut open tube of tip on score mark
  • Do not use if tip is cut prior to opening

Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

Children betweem 2 and 12 years of age: Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age: Do not use

Warnings and Precautions (34071-1)

Warnings

For external use only

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 medical 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 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.

Section 50570-1 (50570-1)

Do not use

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

Inactive ingredients cholecalciferol, mineral oil, phenoxyethanol (and) hydroxyacetophenone (and) caprylyl glycol (and) water, propylene glycol, prunella vulgaris leaf extract, retinyl palmitate (vitamin A palmitate), tocopherol, tocopherol acetate (vitamin E acetate), zea mays (corn) oil

Section 51945-4 (51945-4)

#1

ORAL PAIN

RELIVER

BRAND

FOR ADULTS

2 Active

Ingredients

Orajel

Instant Pain Relief

FOR COLD SORES

Fast-Acting Cream

DOUBLE MEDICATED

Relieves Pain & Itching

Moisturizing Barrier Stays in Place

Paraben Free

TOPICAL ANESTHETIC/SKIN PROTECTANT

NET WT 0.125 OZ (3.5 g)

Section 53413-1 (53413-1)

Questions or comments?call us at 1-800-952-5080M-F 9am-5pm or visit our website at www.orajel.com

Section 55105-1 (55105-1)

Topical anesthetic

Skin protectant

Section 55106-9 (55106-9)

Benzocaine 20%

White petrolatum 73.64%


Advanced Ingredient Data


Raw Label Data

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