5820635 Walgreens Mouth Sore Relief (kanka, 8015303)

5820635 Walgreens Mouth Sore Relief (kanka, 8015303)
SPL v4
SPL
SPL Set ID 253d7ea2-e48e-c7d7-e063-6394a90ae001
Route
ORAL
Published
Effective Date 2024-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Oleth-10 Dimethyl Isosorbide Polyethylene Glycol 300 Benzoin, (+/-)- Acrylate/butylaminoethyl Methacrylate/methyl Acrylate/methyl Methacrylate/octylacrylamide Copolymer (40000 Wamw) Cetylpyridinium Chloride Benzyl Alcohol Propylene Glycol Sucralose Ethylcellulose, Unspecified Alcohol Ricinus Communis Seed Tannic Acid

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-31

Description

Benzocaine 20%


Medication Information

Warnings and Precautions

Methemoglobinemia warning: use of this product may cuase methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • plae, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness of lightheadedness
  • fatigue or lack of energy

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

Indications and Usage

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

Dosage and Administration

adults and children 2 years of age and over: to assure formation of long0lasting film coating, dry affected area and apply medication undiluted with a cotton swab or fingertip; allow a few seconds for coating to for; 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: do not use

Description

Benzocaine 20%

Section 50565-1

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacylamide/acrylates/butylaminoethyl/methylacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil , SD alcohol 38B, sucralose, tannic acid

Section 51945-4

Section 55105-1

Oral anesthetic/analgesic

Section 55106-9

Benzocaine 20%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

adults and children 2 years of age and over: to assure formation of long0lasting film coating, dry affected area and apply medication undiluted with a cotton swab or fingertip; allow a few seconds for coating to for; 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: do not use

Warnings and Precautions (34071-1)

Methemoglobinemia warning: use of this product may cuase methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • plae, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness of lightheadedness
  • fatigue or lack of energy

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

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacylamide/acrylates/butylaminoethyl/methylacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil , SD alcohol 38B, sucralose, tannic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral anesthetic/analgesic

Section 55106-9 (55106-9)

Benzocaine 20%


Advanced Ingredient Data


Raw Label Data

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