Orajel SEVERE PM Toothache & Gum Relief Plus TRIPLE MEDICATED
Orajel Instant Pain Relief by
Drug Labeling and Warnings
Orajel Instant Pain Relief by is a Otc medication manufactured, distributed, or labeled by Church Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
ORAJEL INSTANT PAIN RELIEF SEVERE PM- benzocaine 20%, menthol, benzalkonium chloride cream
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.
----------
Orajel SEVERE PM Toothache & Gum Relief Plus
TRIPLE MEDICATED
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
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
Stop use and ask a physician 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 - cut open tip of tube on score mark
- Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
- Children under 12 years of age - Should be supervised in the use of this product
- Children under 2 years of age - Ask a physicaian or healthcare provider
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, chamomile, 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
Principal Display Panel
Principal Display - OJFC-31854-06
#1 Oral Pain Reliever
for Toothache
Orajel Instant Pain Relief
SEVERE PM
Toothache & Gum Relief Plus
TRIPLE MEDICATED
Nigthtime Formula with Chamomile
20% Benzocaine to Relieve Oral Pain
Antiseptic to Help Prevent Infection
Menthol to Soothe
ORAL PAIN RELIEVER/ANTISEPTIC NET WT 0.25 OZ (7.0g) LONG-LASTING CREAM
| ORAJEL INSTANT PAIN RELIEF
SEVERE PM
benzocaine 20%, menthol, benzalkonium chloride cream |
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
| Labeler - Church & Dwight Co., Inc. (001211952) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Church Dwight Co., Inc. | 043690812 | manufacture(10237-748) | |