Oral Analgesic
FDA Label NDC 41250-703

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc. for the product Oral Analgesic (NDC 41250-703). 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 uses, otc - do not use, otc - ask doctor, otc - keep out of reach of children, directions, inactive ingredients, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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
Carton Image (59589)

Carton Image (59589)




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