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

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Oral Gel

Budpak Inc.

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient

Purpose

Purpose

Uses

Uses
  • toothache  
  • canker sores  
  • cold sores  
  • fever blisters  
  • minor dental procedures
Warnings
  • do not use for more than 7 days unless directed by a dentist or a doctor
  • if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
When using this product
  • avoid contact with the eyes  
  • do not exceed recommended dosage
Stop using and ask a doctor
  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Keep this and all drugs out of reach of children
Directions
  • cut open tip of tube
  • apply to the affected area 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 the product
  • children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor
Other information
  • store at room temperature
  • Lot No. and Exp. Date: see box or see crimp of tube
Inactive Ingredients

Oral Gel

Oral Gel

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:27293-012
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 20 g

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
propylene glycol
sorbic acid
METHYLPARABEN
PROPYLPARABEN
FD&C YELLOW NO. 5
FD&C RED NO. 40

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:27293-012-14 14 in 1 TUBE
2 NDC:27293-012-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-02-01


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Be sure to consult your doctor before taking any medication!
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