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  5. Label Information: Orajel Instant Pain Relief Severe

FDA Label for Orajel Instant Pain Relief Severe

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. OTHER INFORMATION
    6. INACTIVE INGREDIENTS
    7. QUESTIONS OR COMMENTS?
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orajel Instant Pain Relief Severe 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.

Active Ingredient



Benzocaine 20%

Menthol 0.25%

Benzalkonium Chloride 0.1%


Purpose



Oral pain reliever

Oral Pain reliever

Antiseptic


Use



  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

Warnings



Allergy alert: do not use this product if you have a histoy of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics


Other Information



  • do not use if tube tip is cut prior to opening
  • this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously
  • Orajel Severe Pain Formula will stay in place for extended duration of relief
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive Ingredients



cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin


Questions Or Comments?



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


Package Label.Principal Display Panel



#1

ORAL PAIN

Reliever for

Toothache

Now with 3X MORE

Active Ingredients vs. Store Brand

ORAJEL™

Instant Pain Relief

SEVERE

Toothache & Gum Relief Plus

Triple Medicated

20% Benzocaine to Relieve Oral Pain

Antiseptic to Help Prevent Infection

Menthol to Soothe

Oral Pain Reliever NET WT 0.33 OZ (9.4g)

Long-Lasting Cream

OJFC-32501-06

OJFC-32501-06.jpg - OJFC 32501 06

OJFC-32501-06.jpg - OJFC 32501 06


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