Maximum Strength Equate Orasol

Maximum Strength Equate Orasol
SPL v3
SPL
SPL Set ID 08404780-8252-4484-b1c3-8970803f74f8
Route
ORAL
Published
Effective Date 2024-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer 940 D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Methylparaben Polyethylene Glycol 3350 Propylene Glycol Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-30

Description

Benzocaine 20%

Purpose

Oral Pain Reliever


Medication Information

Purpose

Oral Pain Reliever

Description

Benzocaine 20%

Uses
  • temporary relief of occasional minor irritation, pain and sore mouth
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

Methemoglobinema Warning:Use of this product may cause Methemoglobinema, a serious condition that must be treated promptly becasue it reduces the amount of oxygem carried in the blood. This can occur even if you have used this product before. Stop use and seek immeditate medical attention if you or a child in yuor 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.

Purpose 

Oral Pain Reliever

Do Not Use
  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
Drug Facts

Directions 
  • do not use tube if it is cut prior to opening
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
  • apply to affected area up to four times daily or as directed by a dentist or physician
  • Adults and children 2 years of age and older: Apply to affected area
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a doctor
Active Ingredient

Benzocaine 20%

Other Information 

store at a controlled room temperature 68°- 77°F (20°-25°C)

Inactive Ingredients

Benzyl Alcohol, Carbomer, D&C Yellow No 10, FD&C Blue No 1, FD&C Red No 40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

Principal Display Panel 

NDC 79903-966-09

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

Stop Use and Ask A Doctor If 
  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens

Structured Label Content

Uses
  • temporary relief of occasional minor irritation, pain and sore mouth
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.

Warnings

Methemoglobinema Warning:Use of this product may cause Methemoglobinema, a serious condition that must be treated promptly becasue it reduces the amount of oxygem carried in the blood. This can occur even if you have used this product before. Stop use and seek immeditate medical attention if you or a child in yuor 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.

Purpose 

Oral Pain Reliever

Do Not Use
  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
Drug Facts

Directions 
  • do not use tube if it is cut prior to opening
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
  • apply to affected area up to four times daily or as directed by a dentist or physician
  • Adults and children 2 years of age and older: Apply to affected area
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a doctor
Active Ingredient (Active ingredient)

Benzocaine 20%

Other Information  (Other information )

store at a controlled room temperature 68°- 77°F (20°-25°C)

Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Carbomer, D&C Yellow No 10, FD&C Blue No 1, FD&C Red No 40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

Principal Display Panel 

NDC 79903-966-09

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )
  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens

Advanced Ingredient Data


Raw Label Data

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