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  5. Label Information: Baby Teething Oral Pain Reliever

FDA Label for Baby Teething Oral Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTHER
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 IngredientBenzocaine 7.5%

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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