5820340 Rite Aid Prof Str Mouth Pain Liq

5820340 Rite Aid Prof Str Mouth Pain Liq
SPL v19
SPL
SPL Set ID 31ce0cb3-a43a-41bd-b030-21f91f2b1368
Route
ORAL
Published
Effective Date 2013-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Alcohol Ethylcelluloses Tannic Acid Cetylpyridinium Chloride Sucralose Benzyl Alcohol Propylene Glycol Oleth-10 Dimethyl Isosorbide Ricinus Communis Seed Water Polyethylene Glycol 300 Benzoin Resin Menthol

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-01 Until 2026-11-30

Description

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


Medication Information

Warnings and Precautions

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.

Dosage and 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

Description

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

Section 50565-1

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



Center right away.

Section 51945-4

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

Active Ingredient

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

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.


Structured Label Content

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

Dosage and Administration (34068-7)

• 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

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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



Center right away.

Section 51945-4 (51945-4)

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

Active Ingredient (Active ingredient)

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

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 (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.


Advanced Ingredient Data


Raw Label Data

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