Orajel Instant Relief for Teething Pain - Single Use Swabs

Orajel Instant Relief for Teething Pain by

Drug Labeling and Warnings

Orajel Instant Relief for Teething Pain 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]

ORAJEL INSTANT RELIEF FOR TEETHING PAIN- 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 Instant Relief for Teething Pain - Single Use Swabs

Active ingredient

Benzocaine 7.5%

Purpose

Oral Pain Reliever

Use

For the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.

Warnings
Allergy Alert: do not use this product if our child has 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 told to do so by a physician or healthcare provider

When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician.

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

  • hold swab with solid white tip down
  • bend and snap open swab tip at the colored rings. Throw away the broken off end before use. Wait 30-40 seconds for product to flow down into swab tip
  • apply to the affected area up to 4 times daily or as directed by a physician or healthcare provider
  • for infants under 2 years of age,consult a physician or healthcare provider

Inactive ingredients flavor, polyethylene glycol, purified water, red 33, sodium saccharin

Stop use and ask a physician if sore mouth symptoms do not improve in 7 days; irritation, pain or redness does not go away; swelling, rash or fever develops

Other information do not use if label seal is broken prior to purchase, or if colored rings on tip of swab are not pink

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

No.1 TEETHING BRAND

recommended by Pediatricians

Orajel



Instant Relief

for Teething Pain

SINGLE USE SWABS berry flavored swabs

with convenient carrying case

12 UNIT-DOSE SWABS BENZOCAINE 7.5%

NET 0.06 FL OZ (1.8mL) TOTAL ORAL PAIN RELIEVER FOR TEETHING

carton image carton image

ORAJEL INSTANT RELIEF FOR TEETHING PAIN 
benzocaine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10237-736
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10237-736-1212 in 1 CARTON08/01/201012/31/2019
11.8 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/01/201012/31/2019
Labeler - Church & Dwight Co., Inc. (001211952)

Revised: 1/2020
 
Church & Dwight Co., Inc.