SPL v2
SPL
SPL Set ID 7cee7234-32cd-4bf3-8a6c-0882585eec7f
Route
ORAL
Published
Effective Date 2021-12-20
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 300 Polyethylene Glycol 400 Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-19

Description

Drug Facts

Purpose

Oral Pain Reliever


Medication Information

Purpose

Oral Pain Reliever

Description

Drug Facts

Uses
  • temporary relief of occasional minor irritation, pain and sore mouth
Section 42229-5

Drug Facts

Section 50565-1

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

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

Benzocaine 20%

Other Information
  • store at a controlled room temperature 59°-86°F (15°-30°C)
Inactive Ingredients

Benzyl Alcohol, Carbomer, D&C YellowNo.10, FD&C Blue No1, FD&C Red No 40, Glycerin, Methylparaben, Propylparaben, Polyethlene Glycol, Propylene Glycol, Sodium Saccharin 

Stop Use and Ask A Doctor If
  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens
Principal Display Panel – 0.33oz Tube Label

 Walgreens                             NDC 0363-5061-33

Oral Pain Relief

Maxium Strength GEL

Fast Toothache Pain Reliever 

20 % Benzocaine Topical Gel 

Made in the USA

NET WT. 0.33 OZ (9.35g)

Principal Display Panel – 0.33oz Carton Label

Walgreens              NDC 0363-5061-33

Oral Pain Relief

Maxium Strength GEL

Fast Toothache Pain Reliever

20% Benzocaine Topical Gel 

NET WT. 0.33 OZ (9.35g)

Made in the USA


Structured Label Content

Uses
  • temporary relief of occasional minor irritation, pain and sore mouth
Section 42229-5 (42229-5)

Drug Facts

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

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
Do Not Use (Do not use)
  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
Active Ingredient

Benzocaine 20%

Other Information (Other information)
  • store at a controlled room temperature 59°-86°F (15°-30°C)
Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Carbomer, D&C YellowNo.10, FD&C Blue No1, FD&C Red No 40, Glycerin, Methylparaben, Propylparaben, Polyethlene Glycol, Propylene Glycol, Sodium Saccharin 

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
Principal Display Panel – 0.33oz Tube Label

 Walgreens                             NDC 0363-5061-33

Oral Pain Relief

Maxium Strength GEL

Fast Toothache Pain Reliever 

20 % Benzocaine Topical Gel 

Made in the USA

NET WT. 0.33 OZ (9.35g)

Principal Display Panel – 0.33oz Carton Label

Walgreens              NDC 0363-5061-33

Oral Pain Relief

Maxium Strength GEL

Fast Toothache Pain Reliever

20% Benzocaine Topical Gel 

NET WT. 0.33 OZ (9.35g)

Made in the USA


Advanced Ingredient Data


Raw Label Data

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