ORAJEL INSTANT PAIN RELIEF MAXIMUM- benzocaine 20% liquid

Orajel Instant Pain Relief by

Drug Labeling and Warnings

Orajel Instant Pain Relief 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 ingredients

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain due to

• toothaches
• canker sores
• minor injury of the mouth and gums
• minor irritation of the mouth and gums caused by dentures

Warnings

Allergy alert: do not use this product if you have a histoy 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

ASK DOCTOR

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

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 over -

• Hold swab with solid white tip down
• Bend and snap open swab tip with the colored rings
• Apply product to the cavity and around gum surrounding the teeth
• Use up to 4 times daily or as directed by a physician or healthcare provider
• 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 physician or healthcare provider

Other information

• do not use if label seal is broken prior to purchase or if the colored rings on tip are not blue
• this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
• do not use continuously

Inactive ingredients

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

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

Touch-Free Applicator

#1 Oral Pain Reliever
for Toothache

Orajel Instant Pain Relief

MAXIMUM
Toothache & Oral Pain Relief

20% Benzocaine to Relieve Oral Pain

Toothache Canker Sores

Gum Pain Denture Pain

Cheek Bites

ORAL PAIN RELIEVER 12-UNIT DOSE SWABS 0.06 FL. OZ (1.8ML) TOTAL SINGLE-USE SWABS

INGREDIENTS AND APPEARANCE

ORAJEL INSTANT PAIN RELIEF  MAXIMUM
benzocaine 20% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-755
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

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-755-12	12 in 1 CARTON	08/11/2010	03/31/2023
1		0.15 g 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	08/11/2010	03/31/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
SwabPlus, Inc.		876441549	manufacture(10237-755)