FDA Label for Meijer Maximum Strength Oral Pain Relief
View Indications, Usage & Precautions
Meijer Maximum Strength Oral Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Meijer Distribution 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 ingredients Purpose
Benzocaine 20%..............................Oral pain reliever
Benzalkonium chloride 0.1%............Antiseptic
Otc - Purpose
Use
- for the temporary relief of pain due to toothaches
- to help protect against infection in minor oral irritation
Warnings
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
Otc - Do Not Use
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
Otc - Stop Use
Stop use and ask a physician if
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
- allergic reaction occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions
- cut open tip of tube on score mark
Adults and children 2 years of age and over Apply a small amount of product to the cavity around gum surrounding the teeth. Children under 12 years of age Should be supervised in the use of this product Children under 2 years of age Ask a physician or healthcare provider
Storage And Handling
Other information
- do not use if tube tip is cut prior to opening
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Inactive Ingredient
Inactive ingredients glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol
Dosage & Administration
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
Made in Korea
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