Orajel for Cold Sores description, usages, side effects, indications, overdosage, supplying and lots more!

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Orajel for Cold Sores

Church & Dwight Co., Inc.

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENTS

Benzalkonium chloride, 0.13%
Benzocaine, 5%

Purpose

PURPOSE

Cold Sore / Fever Blister Treatment; Topical Antiseptic
Pain Relief During Applications

Uses

USES
  • to treat cold sores / fever blisters
  • to help guard against infection
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

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.

INACTIVE INGREDIENTS
isopropyl alcohol (70% v/v), water

Questions or coments? call us at 1-800-952-5080 M-F ET or visit our website at www.orajel.com

NEW
Orajel

Instant Pain Relief

COLD SORES


HEALING BEGINS

SINGLE DOSE
Cold Sore

ONE DAY


Orajel for Cold Sores
Orajel for Cold Sores

Orajel for Cold Sores

Benzalkonium Chloride, Benzocaine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-741
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
benzalkonium chloride 0.13 mg
BENZOCAINE Benzocaine 0.5 mg

Inactive Ingredients

Ingredient Name Strength
ISOPROPYL ALCOHOL
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 0.6 in 1 VIAL
2 NDC:10237-741-04 2 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2012-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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