ORAJEL FOR ALL MOUTH SORES MAXIMUM STRENGTH- benzocaine swab

Orajel for All Mouth Sores by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

INDICATIONS & USAGE

Use for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums.

WARNINGS

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 dentist or doctor

ASK DOCTOR

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

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

Directions

• Adults and children 2 years of age and older:
  • Hold swab with solid white tip down
  • Bend and snap open swab tip with the colored rings
  • Apply product to affected area
  • Use up to 4 times daily or as directed by a dentist or doctor
  • Discard swab after application
• Children under 12 years of age: Should be supervised in the use of this product
• Children under 2 years of age: Ask a dentist or doctor

OTHER SAFETY INFORMATION

Other information do not use if label seal is broken prior to purchase or if colored rings on tip are not orange

INACTIVE INGREDIENT

Inactive ingredients flavor, polyethylene glycol, water, red 40, sodium saccharin, yellow 5

QUESTIONS

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

PURPOSE

Oral pain reliever

PRINCIPAL DISPLAY PANEL

#1 Pharmacist Recommended

Brand for Adult Oral Pain

medicated swabs

Orajel

Instant Pain Relief

FOR ALL MOUTH SORES

MAXIMUM STRENGTH

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

12 UNIT DOSE SWABS NET 0.06 FL OZ (1.8 ML) TOTAL

BENZOCAINE 20% ORAL PAIN RELIEVER

INGREDIENTS AND APPEARANCE

ORAJEL FOR ALL MOUTH SORES  MAXIMUM STRENGTH
benzocaine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-709
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.2 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-709-12	12 in 1 CARTON	08/01/2010	03/31/2022
1		1.8 mL in 1 APPLICATOR; 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	08/01/2010	03/31/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
SwabPlus, Inc.		116984439	manufacture(10237-709)