Otc - Active Ingredient
Active ingredient PurposeBenzocaine 10%............................................Oral Pain Reliever
Cvs Fast Acting Baby Teething
FDA Label NDC 59779-829
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Fast Acting Baby Teething (NDC 59779-829). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses- temporary relieves of sore gums due to teething in infants and children 4 months and older
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If case of overdose or allergic reaction, seek medical attention or contacta Poison Control Center right away.
Indications & Usage
Uses- temporary relieves of sore gums due to teething in infants and children 4 months and older Other information- do not use if tube tip is cut prior to opening
Warnings
Warnings Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as butacaine, benzocaine, procaine, or other "caine" anestheticsDo not use - more than directed - for more than 7 days, unless directed by a dentist or doctorWhen using this product - fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. if these symptoms persist, contact your dentist or doctor.Stop use and consult a dentist or doctor if: - sore mouth symptoms do not get better in 7 days- irritation, pain or redness does not go away - swelling, rash or fever developsKeep out of the reach of children.In case of overdose or allergic reaction, seek medical attention or contact a Poison Control Center right away.
Dosage & Administration
Directions - wash hands - cut open tip of tube on score mark- use your fingertip or cotton swab to apply a small, pea-size amount of product- apply to the affected area up to four times daily or as directed by a dentist or doctor- for infants under 4 months of age, ask a dentist or doctorOther informationdo not use if tube tip is cut prior to opening
Inactive Ingredient
Inactive IngredientsFD and C red no. 4, flavor, glycerin, propylene glycols, purified water, sodium saccharine, sorbic acid, sorbitol
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