Active Ingredients
Benzocaine 20%
Family Wellness Gel
FDA Label NDC 55319-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc for the product Family Wellness (NDC 55319-108). 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 active ingredients, purpose, uses, warnings, when using this product:, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever
Uses
temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- canker sores
- minor dental procedures
- dentures
- sore gums
- braces
Warnings
Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
- for teething
- in children under 2 years of age
Allergy alert:Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Do not use:
When Using This Product:
- avoid contact with the eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless directed by a doctor/dentist
Stop Use And Ask A Doctor If
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness lasts or worsens
- swelling, rash, or fever develops
Keep Out Of Reach Of Children
Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
| adults and children 2 years of age and over | apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist |
| children under 12 years of age | adult supervision should be given in the use of this product |
| children under 2 years of age | do not use |
- For denture irritation:
- apply thin layer to the affected area
- do not reinsert dental work until irritation/pain is relieved
- rinse mouth well before reinserting
Other Information
- store at 20-25°C (68-77°F)
- do not refrigerate
Inactive Ingredients
benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid
Package Label.Principal Display Panel
Principal Display Panel (Benzocaine)
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