FDA Label for Orajel Severe Toothache Maximum Strength Fast-acting Formula
View Indications, Usage & Precautions
Orajel Severe Toothache Maximum Strength Fast-acting Formula Product Label
The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient
Benzocaine 20%
Otc - Purpose
Purpose
Oral pain reliever
Indications & Usage
Use for the temporary relief of pain due to toothaches
Warnings
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
Otc - Do Not Use
Do not use
- more than directed
- for more than 7 days unless told to do so by a dentist or doctor
Otc - Stop Use
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
Otc - 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
- 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 Safety Information
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 Ingredient
Inactive ingredients alcohol (54.6% by volume), flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5
Otc - Questions
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
#1 ORAL PAIN RELIEVER
FOR TOOTHACHE
Orajel liquid
Instant Pain Relief
for SEVERE TOOTHACHE
MAXIMUM STRENGTH
FAST-ACTING FORMULA
NET CONTENTS 0.45 FL OZ (13.3 ML) ORAL PAIN RELIEVER BENZOCAINE 20%
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