Otc - Active Ingredient
Active IngredientBenzocaine 7.5%
Baby Teething Oral Pain Reliever
FDA Label NDC 27293-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Budpak Inc. for the product Baby Teething Oral Pain Reliever (NDC 27293-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposeAnesthetic
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
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
- 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 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
Other
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
Package Label.Principal Display Panel
Package Label
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