RITE AID PROFESSIONAL STRENGTH- benzocaine liquid

Rite Aid by

Drug Labeling and Warnings

Rite Aid by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Lornamead, CSR Cosmetic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzocaine 20.0%  ...................................................................... Oral anesthetic / analgesic

Use

for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

WARNINGS

For oral use only
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
When using this product Do not use for more than 7 days unless told to do so 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

Directions

to assure formation of long lasting film coating, dry affected area and apply
medication undiluted with applicator. allow a few seconds for coating to form. use up to 4 times
daily, or as directed by a dentist or doctor. children 12 years of age should be supervised in
the use of this product. children under 2 years of age:ask a dentist or doctor

DOSAGE & ADMINISTRATION

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: consult a dentist or doctor

Other Information

do not purchase if package has been opened
store at 20 - 25 C (68-77F)
close cap tightly after use to avoid evaporation
avoid contact with eyes
avoid contact with clothing and household furniture surfaces to avoid possible staining
this is a personal care item, and should be used by one individual only

Inactive ingredients

Benzyl Alcohol, Cetylpyridinium
Chloride, Compound Benzoin Tincture,
Dimethyl Isosorbide, Ethylcellulose,
Flavor, Octylacrylamideacrylates/
butylaminoethyl/methacrylate
Copolymer, Oleth-10, PEG-6, Propylene
Glycol, Ricinus Communis (Castor)
Seed Oil, SD Alcohol 38B, Sucralose,
Tannic Acid.

PRINCIPAL DISPLAY PANEL

Bottle

Blister

INGREDIENTS AND APPEARANCE

RITE AID  PROFESSIONAL STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-5340
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
ALCOHOL (UNII: 3K9958V90M)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
TANNIC ACID (UNII: 28F9E0DJY6)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OLETH-10 (UNII: JD797EF70J)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
BENZOIN RESIN (UNII: GK21SBA74R)

Product Characteristics
Color	yellow (orange to reddish orange)	Score
Shape		Size
Flavor	MINT (Mint Flavor #25797)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-5340-8	1 in 1 BLISTER PACK	01/01/2014
1	NDC: 11822-5340-1	14.17 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2014

Labeler - Rite Aid (014578892)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions		243501959	manufacture(11822-5340) , pack(11822-5340)