FDA Label for Budpak Baby Teething Oral Pain Reliever
View Indications, Usage & Precautions
Budpak Baby Teething Oral Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Budpak Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient
Benzocaine 7.5%
Otc - Purpose
Purpose
Oral pain reliever
Indications & Usage
Use
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, benzocaine or other "caine" anesthetics.
Otc - Do Not Use
Do not use
- for more than 7 days unless told to do so by a physician
- more than directed
Otc - 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.
Otc - Stop Use
Stop using and ask a dentist or physician if
- sore mouth symptoms do not get better in 7 days
- irritation, pain or redness does not go away
- swelling, rash or fever develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In cases of overdose or allergic reaction, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions
- do not use if tube safety seal is broken
- wash hands
- break seal on tube
- use your fingertip or cotton applicator to apply a small pea-size amount of Budpak 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
Other information
- Store at 15°C to 25 °C (59°F to 77°F)
- Lot No. & Exp. Date: see crimp of tube
PRINCIPAL DISPLAY PANEL
BUDPAK BABY TEETHING PAIN RELIEVER GEL
Benzocaine 7.5%
NET WT 0.5 OZ. (14 g)
Inactive Ingredient
Inactive Ingredients
Glycyrrhizin Ammoniated, Glycerin, Polyethylene glycol, Purified water, Sodium saccharin, Sorbic acid, Sorbitol, Flavor, Red #40.
Package Label.Principal Display Panel
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