Orajel for Codl Sores Relief and Concealer

Dosage form: cream
Ingredients: BENZOCAINE 200mg in 1g, CAMPHOR (NATURAL) 30mg in 1g, ALLANTOIN 5mg in 1g, DIMETHICONE 20mg in 1g, MENTHOL 10mg in 1g, PETROLATUM 640mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-726

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.

DRUG FACTS

Active Ingredients         Purpose

Allantoin 0.5%               Skin protectant

Benzocaine 20%           Topical analgesic

Camphor 3%                 Topical analgesic

Dimethicone 2%            Skin protectant

Menthol 1%                   Topical analgesic

White petrolatum 64%   Skin protectant

Uses   temporarily relieves pain and dryness; softens crust (scabs) associated with cold sore, fever blisters

Warnings

 For external use only

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 for more than 7 days unless told to do so by a dentist or doctor

When using this product do not get into eyes

Stop use and ask a doctor if conditions worsens; symptoms do not improve in 7 days; symptoms clear up and occur again within a few days

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.


Directions

twist base clockwise ot dispense.  On first usage, it may take up to 15 full turns to load the brush.  Subsequent uses should require only 1 to 2 turns;  blend well until green tint disappears; after each use, wipe brush with a clean dry tissue and replace cap



Adults and children 2 years of age and older     Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age                        Should be supervised in the use of this product.

Children under 2 years of age                          Ask a doctor


Other Information
do not use if package is torn, cut or otherwise damaged; store at 15-30C (59-86F) under dry conditions; this is a personal care item and should be used by one individual only

Inactive ingredients
caprylic/capric triglyceride, prunella vulgaris leaf extract, propylene glycol, water, tocopheryl acetate, retinyl palmitate, zea mays (corn) oil, tocopherol, cholecalciferol, titanium dioxide, yellow 5 lake, iron oxides, blue 1 lake

Questions or comments?  call us at 1-800-952-5080 Mon-Fri 9am-5pm ET or visit our website at www.orajel.com

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ORAJEL FOR CODL SORES RELIEF AND CONCEALER 
allantoin benzocaine camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-726
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)30 mg  in 1 g
ALLANTOIN (ALLANTOIN) ALLANTOIN5 mg  in 1 g
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL10 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM640 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES 
PRUNELLA VULGARIS 
PROPYLENE GLYCOL 
WATER 
.ALPHA.-TOCOPHEROL ACETATE, D- 
VITAMIN A PALMITATE 
CORN OIL 
ALPHA-TOCOPHEROL 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 5 
IRON 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:10237-726-051 TUBE, WITH APPLICATOR (TUBE) in 1 BLISTER PACK
11.4 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/19/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Direct Merchantdising Inc.076693183manufacture

Revised: 07/2010
 
Church & Dwight Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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