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

BABY TEETHING ORAL PAIN RELIEVER
benzocaine gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Budpak Inc. (183224849)

Name	Address	ID/FEI	Business Operations
Establishment
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.		529836561	manufacture