RxNorm Names
Review RxNorm Normal Forms
MOUTH SORE RELIEF PROFESSIONAL STRENGTH
(benzocaine)
liquid
[CVS Pharmacy]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1b7209f6-8368-47fa-8df2-b049613b8c1b| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Active ingredient
Benzocaine 20.0% (w/w) ...................................................................... Oral anesthetic/analgesicUse
for the temporary relief of pain due to canker sores, minor irritation of the mouth andgums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums
For oral use only
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such asprocaine, butacaine, benzocaine or other “caine” anesthetics
When using this product • do not use for more than 7 days unless directed by a dentist or doctor.
If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens;
or if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed
recommended dosage.
Directions
• to assure formation of long-lasting film coating, dry affected area and applymedication undiluted with applicator • allow a few seconds for coating to form
Other Information
• do not use if package has been opened• store at 20-25˚C (68-77°F)
• close cap tightly after use to avoid evaporation
• avoid contact with eyes
• avoid contact with clothing and household/furniture surfaces to prevent possible staining
• this is a personal care item, and should be used by one individual only
Inactive ingredients
Benzyl Alcohol, CetylpyridiniumChloride, Compound Benzoin Tincture,
Dimethyl Isosorbide, Ethylcellulose,
Flavor, Octylacrylamide/acrylates/
butylaminoethyl/methacrylate
Copolymer, Oleth-10, PEG-6, Propylene
Glycol, Ricinus Communis (Castor)
Seed Oil , SD Alcohol 38B, Sucralose,
Tannic Acid.
| MOUTH SORE RELIEF
PROFESSIONAL STRENGTH
benzocaine liquid |
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| Labeler - CVS Pharmacy (062312574) |
| Registrant - Lornamead (126440440) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| CSR Cosmetic Solutions | 243501959 | manufacture(59779-830), pack(59779-830) | |
Revised: 04/2011
Document Id: b8178aba-50dd-4fbb-8352-bdb6ea2980ef
Set id: 1b7209f6-8368-47fa-8df2-b049613b8c1b
Version: 14
Effective Time: 20110419
CVS Pharmacy
