Budpak Baby Teething Oral Pain Reliever
FDA Label NDC 27293-015

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 Budpak Baby Teething Oral Pain Reliever (NDC 27293-015). 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 - 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

Image Of Package Label (Baby Teething)

Image Of Package Label (Baby Teething)

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