ORAJEL TOOTHACHE STRIPS- benzocaine, menthol strip

Orajel by

Drug Labeling and Warnings

Orajel by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Biofilm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 15 mg

Menthol 2.5 mg

PURPOSE

Benzocaine - Oral Pain Reliever

Menthol - Oral Pain Reliever

INDICATIONS & USAGE

Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums

WARNINGS

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 to the 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 fatique 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

Do not use more than directed for more than 7 days unless directed by a physician or healthcare provider for teething in children under 12 years of age

STOP USE

Stop use and ask a physician if swelling, rash or fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

OTHER SAFETY INFORMATION

INACTIVE INGREDIENT

acid blue 9, glycerin, PEG-8, PEG-90, polycarbophil, potassium sorbate, pullulan, PVP, titanium dioxide, water.

QUESTIONS

Questions call us at 800 952 5080 Monday through Friday 9am to 5pm or visit our website at www orajel com

PRINCIPAL DISPLAY PANEL

#1 ORAL PAIN

Reliever Brand

For Toothache

SLOW DISSOLVING STRIPS

For Lasting Relief

Orajel™

TOOTHACHE STRIPS

MEDICATED FOR TOOTHACHE & GUM

INSTANT & TARGETED PAIN RELIEF

Long-Lasting Pain Relief

Maximum level of Pain Relief with 15mg Benzocaine*

Stays in place for Targeted Relief

Soothes gums with Menthol

Cool Mint Taste

8 STRIPS

Individually Wrapped

Oral Pain Reliever

INGREDIENTS AND APPEARANCE

ORAJEL  TOOTHACHE STRIPS
benzocaine, menthol strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-776
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	150 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PULLULAN (UNII: 8ZQ0AYU1TT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K90 (UNII: RDH86HJV5Z)
POLYCARBOPHIL (UNII: W25LM17A4W)
ACID BLUE 9 AMMONIUM (UNII: 86R7G3C26F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-776-01	1 in 1 CARTON	01/15/2019
1		8 g in 1 PACKAGE; 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	11/05/2018

Labeler - Church & Dwight Co., Inc. (001211952)

Registrant - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Biofilm		734555951	manufacture(10237-776)