FDA Label for Oral Analgesic Maximum Strength

View Indications, Usage & Precautions

Oral Analgesic Maximum Strength 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.

Uses



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

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.


Flammable:  keep away from fire or flame. Avoid smoking during applications and until product has dried.

Otc - Do Not Use



When using this product avoid contact with the eyes, do not use more than directed, for more than 7 days unless directed by a dentist or doctor

Otc - Ask Doctor



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 case of overdose, get medical help or contact a Poison Control Center right away


Directions



Directions   remove imprinted safety seal from bottle cap

Adults and children 2 years of age and over                  Apply product with cotton swab or clean fingertip to the affected area.
                                                                                 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 imprinted bottle seal is broken or missing prior to opening

Inactive Ingredients



Inactive ingredients  ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid


Otc - Questions



Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm ET


Package Label.Principal Display Panel



Meijer

Oral Analgesic Liquid
maximum strength benzocaine 20%

For Fast Relief of Oral Pain Caused by:
Toothache, Denture or Gum Irritations,
Cold or Canker Sores

Oral Analgesic Liquid
maximum Strength
safety sealed tube tip

NET WT. 0.45 OZ (13.3g)

Carton Image




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