RED CROSS CANKER SORE- benzocaine ointment 
The Mentholatum Company

Disclaimer: 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.

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Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral anesthetic/analgesic

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

Do Not Use

  • for teething
  • in children under 2 years of age

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.

Directions

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

Package/Label Principal Display Panel

Red Cross Canker Sore Oral Anesthetic/Analgesic

Principal Display Panel

RED CROSS CANKER SORE 
benzocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8915
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
CHAMOMILE (UNII: FGL3685T2X)  
COCONUT OIL (UNII: Q9L0O73W7L)  
MYRRH (UNII: JC71GJ1F3L)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8915-11 in 1 BLISTER PACK08/19/1998
17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/19/1998
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-8915)

Revised: 2/2023
Document Id: f4214f3f-a2e7-550a-e053-2a95a90ac97e
Set id: 54cfff96-6665-4b36-a15d-10bf6cf3a1f9
Version: 3
Effective Time: 20230207
 
The Mentholatum Company