Baby Teething Oral Pain Reliever

Budpak Inc.

Drug Facts

FULL PRESCRIBING INFORMATION

Active ingredient

Purpose

Uses

• Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
  

• for more than 7 days unless told to do so by a physician 
  
• more than directed
  

• fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your physician

• sore mouth symptoms do not get better in 7 days
• irritation, pain or redness does not go away
  
• swelling, rash or fever develops

Keep out of reach of childrenDirections

• wash your hands
• use your fingertip or cotton applicator to apply a small pea-size amount of Budpack Baby Teething Gel Medicine.
• Apply to affected area up to 4 times daily or as directed by a dentist or physician.
• for infants under 4 months of age, ask a doctor
  

Other information

•      Store at 15 to 25 C (59-77F)
  

   
Inactive Ingredients

Baby Teething Oral Pain Reliever Benzocaine GEL Product Information Product Type Human otc drug label Item Code (Source) NDC:27293-013 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE Benzocaine 7.5 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:27293-013-14 14 in 1 TUBE 2 NDC:27293-013-01 1 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part356 2010-05-01