BABY TEETHING ORAL PAIN RELIEVER- benzocaine gel

Baby Teething Oral Pain Reliever by

Drug Labeling and Warnings

Baby Teething Oral Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Budpak Inc., Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Benzocaine 7.5%

PURPOSE

Purpose
Anesthetic

INDICATIONS & USAGE

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

WARNINGS

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

Do not use

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

WHEN USING

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 USE

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

Keep out of reach of children. In case of overdose or allergic reaction contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

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
  

SPL UNCLASSIFIED SECTION

Other information

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

   

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

BABY TEETHING ORAL PAIN RELIEVER 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBIC ACID (UNII: X045WJ989B)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-013-01	1 in 1 BOX
1	NDC: 27293-013-14	14 g in 1 TUBE

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	Business Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.		529836561	manufacture