RED CROSS ORAL PAIN RELIEF- benzocaine liquid

Red Cross Oral Pain Relief by

Drug Labeling and Warnings

Red Cross Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Uses

temporarily relieves pain associated with ▪ toothache ▪ canker sores ▪ minor mouth irritation or injury of the mouth and gums caused by dentures or braces

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 do not improve in 7 days
• swelling, rash, or fever develops
• irritation, pain, or redness persists or worsens

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

• using tweezers, immerse cotton pellet in medication
• apply pellet to affected area, then remove
• adults and children 2 years and over: use up to 4 times daily or as directed by a dentist or doctor
• children under 12 years: supervise while using this product
• children under 2 years: do not use

Inactive Ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, propylene glycol, saccharin calcium

Package/Label Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

RED CROSS ORAL PAIN RELIEF 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN CALCIUM (UNII: 5101OP7P2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8902-1	1 in 1 BLISTER PACK	06/01/2013
1		3.7 mL in 1 BOTTLE; 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	06/01/2013

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	MANUFACTURE(10742-8902)