ORAJEL FOR ALL MOUTH SORES MAXIMUM STRENGTH- benzocaine swab
Church & Dwight Co., Inc.

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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Orajel Mouth Sore Medicine, Swabs

Benzocaine 20%

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

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

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.

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

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

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

Oral pain reliever

#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

34006-07

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10237-709-12	12 in 1 CARTON	08/01/2010	05/31/2022
1		1.8 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/01/2010	05/31/2022

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

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

Revised: 8/2020

Document Id: acdd9bf5-ab52-5028-e053-2a95a90abbc4

Set id: 0fd5527f-e4b6-49f6-906d-e4b1ed6b055b

Version: 4

Effective Time: 20200814

Church & Dwight Co., Inc.