Orajel for Cold Sores by Church & Dwight Co., Inc. / James Alexander Corporation / Berkeley Contract Packaging, LLC Orajel for Cold Sores
Orajel for Cold Sores by
Drug Labeling and Warnings
Orajel for Cold Sores by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., James Alexander Corporation, Berkeley Contract Packaging, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
ORAJEL FOR COLD SORES SINGLE DOSE- benzalkonium chloride, benzocaine liquid
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 for Cold Sores
WARNINGS
For external use only. Flammable, keep away from fire or flame.
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
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any ingredient in the product
- more than 3 times per day
- longer than one week unless directed by a physician
Stop use and ask a dentist or physician if
- condition persists or worsens
- symptoms persist for more than 7 days
Ask a physician if
- used to treat deep or puncture wounds, animal bites, or serious burns
- you are pregnant or nursing a baby
When using this product
you may feel a brief stinging sensation when applying it. The sting should go away in a short time.
KEEP OUR OF REACH OF CHILDREN
In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away.
DIRECTIONS
Adults and children over 2 years of age:
- Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using only warm water or alcohol
- Slide off to remove the protective blue paper cover and slide it on the other end-opposite the white applicator tip
- Squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap
- Hold with the white applicator tip down to allow the medication to saturate the tip
- To minimize pain during application gently touch the site of the cold sore with the saturated applicator tip. Once the area is numb, rub the site of the cold sore and the surrounding area. Rub firmly to allow the treatment to deeply penetrate the skin.
- To treat most cold sores, usually one treatment is enough. If your symptoms go away and then return later, apply another dose for the second cold sore
- Do not use more than 3 times per day
- Discard after use.
Children under 2 years of age:
OTHER INFORMATION
- Store at room temperature
-
The ingredients in toothpaste, soft drinks, and some fruit juices can de-activate the active ingredient in Orajel Single Dose.
- For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying the drug.
| ORAJEL FOR COLD SORES
SINGLE DOSE
benzalkonium chloride, benzocaine liquid |
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| Labeler - Church & Dwight Co., Inc. (001211952) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| James Alexander Corporation | 040756421 | manufacture(10237-741) | |