Orajel Maximum Strength
Dosage form: liquid
Ingredients: Benzocaine 0.2mL in 1mL
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-703
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.
Active ingredient
Benzocaine 20%
Purpose
Oral pain reliever
Use for the temporary relief of pain due to toothaches
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
Flammable: keep away from fire or flame. Avoid smoking during application and until product has dried
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
- 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.
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away
Directions
- remove imprinted safety seal from bottle cap
Adults and children 2 years and older Apply product with cotton swab or finger to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor
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 imprinted bottle seal is broken or missing prior to opening
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
- do not use continuously
Inactive ingredients alcohol (54.6% by volume), flavor, polyethylene glycol, purified 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
| ORAJEL
MAXIMUM STRENGTH
benzocaine liquid |
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| Labeler - Church & Dwight Co., Inc. (001211952) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Accupac, Inc. | 071609663 | manufacture | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

