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Name:Baby Teething Oral Pain Reliever
Manufacturer:Budpak Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BABY TEETHING ORAL PAIN RELIEVER  - benzocaine gel 
Budpak Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient
Benzocaine 7.5%

Purpose
Anesthetic

Uses temporarily relieves sore gums due to teething in infants and children 4 months and older

Warnings
  • 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

Do not use
  • for more than 7 days unless told to do so by a physician 
  • more than directed

When using this product

  • 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

Stop using and ask a dentist or 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 children. In case of overdose or allergic reaction contact a Poison Control Center right away

Directions

  • 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 Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40


Package Label
image of package label


BABY TEETHING ORAL PAIN RELIEVER 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:27293-013
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 7.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
PROPYLENE GLYCOL  
SORBIC ACID  
METHYLPARABEN  
PROPYLPARABEN  
FD&C YELLOW NO. 5  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27293-013-01 1 TUBE ( TUBE) in 1 BOX contains a TUBE (27293-013-14)
1 NDC:27293-013-14 14 g in 1 TUBE This package is contained within the BOX (27293-013-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 05/01/2010

Labeler - Budpak Inc. (183224849)
Establishment
Name Address ID/FEI Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd. 529836561 manufacture

Revised: 05/2010 Budpak Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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