FDA Label for Quality Choice Maximum Strength Oral Pain Relieving
View Indications, Usage & Precautions
Quality Choice Maximum Strength Oral Pain Relieving Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association 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 ingredient (each gram contains) Purpose
Benzocaine 20%..........................................................................Oral pain reliever
Otc - Purpose
Uses temporarily relieves pain due to:
- toothache
- canker sores
- cold sores
- fever blisters
- minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Warnings
Warnings Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, bensocaine or other "caine" anesthetics.
Otc - When Using
When using this product
- do not use more than directed
- do not use for more than 7 days unless directed by a doctor/dentist
- do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist
Otc - Stop Use
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash, or fever develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In cases of overdose, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions
- remove cap and apply small amount of Oral Pain Relieving Gel to the cavity and around gum surrounding the teeth
- adults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/dentist
- children under 12 years of age: should be supervised in the use of this product
- children under 2 years of age: ask a doctor/dentist
- For denture Irritation:
- apply thin layer to the affected area
- do not reinsert denture work until irritation/pain is relieved
- rinse mouth well before reinserting
Storage And Handling
Other information
- store at 15° to 25°C (59° to 77°F)
- Lot No. and Exp. Date: See box or crimp of tube
Inactive Ingredient
Inactive ingredients flavor, polyethylene glycols, sodium saccharin, sorbic acid
Dosage & Administration
Distributed By Quality Choice
Novi, MI 48376-0995
Made in Korea
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