Opahl description, usages, side effects, indications, overdosage, supplying and lots more!

Opahl

Dharma Research, inc.
Dharma Research, inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Benzocaine, 20%

Purpose

Oral anesthetic

Uses

For the temporary relief of pain associated with canker sores and minor dental procedures

Warnings

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.

Do not use

this product 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, or fever develops, see your dentist or doctor promptly.

Do not

exceed recommended dosage

Keep out of reach of children

If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control center right away.

Directions

  • Adults and children 2 years of age and older:  Apply to the affected area.  Use up to 4 times daily or as directed by a dentist or doctor.
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a dentist or doctor.

Other Information

Store at room temperature 59-86°F (15-30°C). Protect from freezing and heat.

Inactive Ingredients

FD&C Red #40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol, Water

Opahl

Oral Anesthetic Gel Strawberry Shortcake

with Vitamin E and Xylitol

Gluten Free

1.12 oz (32 g)

Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166

1-877-833-3725

www.dharmaresearch.com

NDC: 53045-106-30

Opahl

Opahl

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53045-106
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 6.4 g

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
POLYETHYLENE GLYCOL 3350
polyethylene glycol 400
saccharin sodium
.ALPHA.-TOCOPHEROL ACETATE
Xylitol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53045-106-30 32 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-11-02


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