FDA Label for Kroger Maximum Strength
View Indications, Usage & Precautions
Kroger Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Kroger. 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.
Active Ingredient
Benzocaine 20.0% ..................................Oral pain reliever
Menthol 0.25% .......................................Oral pain reliever
Benzalkonium Chloride 0.1% ....................Antiseptic
Uses
for the temporary relief of pain due to toothaches
to help protect against infection of minor oral irritation
Warnings
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
When using this product
- do not use more than directed
- for more than 7 days unless told to do so by a dentist or doctor
- swelling rash or fever developes
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
- allergic reaction occurs
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- cut open tip of tubne on score mark
- adults and children 2 years of age and older; apply a small amount of product to the cavity and arround the gum surrounding the teeth
- use up to 4 times daily or as directed by a dentist or doctor.
- Children under 12 years of age should be supervised in the use of this product.
Children under 2 years of age: ask a dentist or doctor.
Other Information
- do not use if tip is cut prior to opening
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
- do not use continuously
- this formula will stay in place for an extended duration of relief
- avoid using toothpaste or drinking softdrinks or fruit juices for at least one hour after applying
Inactive Ingredients
Cellulose Gum, Gelatin, Methyl Salicylate, Mineral Oil, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin
Dosage & Administration
Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of age should be supervised in the use of this product.
Children under 2 years of age: ask a dentist or doctor.
Package Label.Principal Display Panel
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