ORAJEL 3X MEDICATED FOR ALL MOUTH SORES- benzocaine, menthol, zinc chloride gel

Orajel 3X Medicated For All Mouth Sores by

Drug Labeling and Warnings

Orajel 3X Medicated For All Mouth Sores by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzocaine 20%

Menthol 0.1%

Zinc Chloride 0.15%

Purpose

Oral pain reliever and Oral astringent

Uses

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

• more than directed
• for more than 7 days unless directed by a dentist or doctor
• for teething
• in children under 2 years of age

Stop use and ask a doctor if

• 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

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

Other information

do not use if Tamper-Evident Tab is open before first use

Inactive ingredients

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

Questions or comments?

call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

Principal Display Panel

#1 ORAL PAIN RELIEVER FOR TOOTHACHES

Ready-Open Tube Tip

Orajel

3X MEDICATED FOR ALL MOUTH SORES GEL

INSTANT PAIN RELIEF

Canker and Cold Sores Gum Irritation Cheek Bites Irritation from Dentures or Braces

20% Benzocaine to Relieve Oral Pain

Menthol to Soothe Gums

Astringent to Help Protect Sores from Irritation

ORAL PAIN RELIEVER/ASTRINGENT

NET WT

.18 OZ (5.1 g)

INGREDIENTS AND APPEARANCE

ORAJEL 3X MEDICATED FOR ALL MOUTH SORES 
benzocaine, menthol, zinc chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-783
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 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 1 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
POVIDONE (UNII: FZ989GH94E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBIC ACID (UNII: X045WJ989B)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-783-18	1 in 1 PACKAGE	11/01/2019
1		1.8 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-783-42	1 in 1 PACKAGE	11/01/2019
2		4.2 g in 1 TUBE; 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	part348	11/01/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-783)