Church & Dwight Orajel Instant Pain Relief Maximum Toothache & Oral Pain Relief

Orajel Instant Pain Relief MAXIMUM Toothache Oral Pain Relief by

Drug Labeling and Warnings

Orajel Instant Pain Relief MAXIMUM Toothache Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by Swabplus, L.P.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL INSTANT PAIN RELIEF MAXIMUM TOOTHACHE ORAL PAIN RELIEF- benzocaine liquid 
Swabplus, L.P.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Church & Dwight Orajel Instant Pain Relief Maximum Toothache & Oral Pain Relief

Active Ingredients

Benzocaine 20%

Purpose

Oral Pain Reliever

Use

For the temporary relief 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 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

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

Orajel Instant Pain Relief MAXIMUM

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

ORAJEL INSTANT PAIN RELIEF MAXIMUM TOOTHACHE ORAL PAIN RELIEF 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65734-502(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
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-502-12	12 in 1 CARTON	01/01/2019
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	01/01/2019

Labeler - Swabplus, L.P. (116984439)

Revised: 5/2021

Document Id: c25366f9-4e9e-4200-e053-2995a90a94cd

34390-5

Set id: c25366f9-4e9d-4200-e053-2995a90a94cd

Version: 1

Effective Time: 20210514