Drug Facts - Red Cross Canker Sore

Drug Facts - Red Cross Canker Sore
SPL v4
SPL
SPL Set ID 54cfff96-6665-4b36-a15d-10bf6cf3a1f9
Route
TOPICAL
Published
Effective Date 2018-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Aloe Vera Leaf Butylated Hydroxytoluene Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Cetylpyridinium Chloride Chamomile Coconut Oil Myrrh Echinacea Purpurea Glyceryl 1-stearate Menthol, Unspecified Form Mineral Oil Silica Dimethyl Silylate .alpha.-tocopherol Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1998-08-19

Description

Benzocaine 20%

Purpose

Oral anesthetic/analgesic


Medication Information

Purpose

Oral anesthetic/analgesic

Description

Benzocaine 20%

Uses

temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen 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: ▪ pale, gray, or blue colored skin (cyanosis) ▪ headache ▪ rapid heart rate ▪ shortness of breath ▪ dizziness or 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

Directions
  • snip off tip of tube
  • apply to affected area; carefully coat with a protective layer
  • supervise children using this product
  • adults and children 2 years and over: use up to 4 times daily or as directed by a doctor
  • children under 2 years: do not use
Do Not Use
  • for teething
  • in children under 2 years of age
Active Ingredient

Benzocaine 20%

Inactive Ingredients

aloe barbadensis leaf extract, butylated hydroxytoluene, carbomer hompolymer, cetylpyridinium chloride, chamomilla recutita (matricaria) flower extract, cocos nucifera (coconut) oil, commiphora myrrha resin, dimethicone, echinacea purpurea extract, flavor, glyceryl stearate, menthol, mineral oil, silica dimethicone silylate, vitamin E, white petrolatum

When Using This Product
  • do not use for more than 7 days unless directed by a dentist or doctor
  • do not exceed recommended dosage
Stop Use and Ask A Doctor If
  • sore mouth symptoms last more than 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops
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.

Package/label Principal Display Panel

Structured Label Content

Uses

temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures

Purpose

Oral anesthetic/analgesic

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen 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: ▪ pale, gray, or blue colored skin (cyanosis) ▪ headache ▪ rapid heart rate ▪ shortness of breath ▪ dizziness or 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

Directions
  • snip off tip of tube
  • apply to affected area; carefully coat with a protective layer
  • supervise children using this product
  • adults and children 2 years and over: use up to 4 times daily or as directed by a doctor
  • children under 2 years: do not use
Do Not Use
  • for teething
  • in children under 2 years of age
Active Ingredient (Active ingredient)

Benzocaine 20%

Inactive Ingredients

aloe barbadensis leaf extract, butylated hydroxytoluene, carbomer hompolymer, cetylpyridinium chloride, chamomilla recutita (matricaria) flower extract, cocos nucifera (coconut) oil, commiphora myrrha resin, dimethicone, echinacea purpurea extract, flavor, glyceryl stearate, menthol, mineral oil, silica dimethicone silylate, vitamin E, white petrolatum

When Using This Product (When using this product)
  • do not use for more than 7 days unless directed by a dentist or doctor
  • do not exceed recommended dosage
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sore mouth symptoms last more than 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops
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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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