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Orajel Cold Sore Moisturelock

Medically reviewed on July 11, 2016

Dosage form: cream
Ingredients: BENZOCAINE 200mg in 1g, ALLANTOIN 5mg in 1g, CAMPHOR (NATURAL) 30mg in 1g, DIMETHICONE 20mg in 1g, MENTHOL 10mg in 1g, PETROLATUM 640mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-761

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 Cold Sore Moisturelock

Allantoin 0.5%

Benzocaine 20%

Camphor 3%

Dimethicone 2%

Menthol 1%

White petrolatum 64%

Allantoin - Skin protectant

Benzocaine - Topical anesthetic

Camphor - Topical analgesic

Dimethicone - Skin protectant

Menthol - Topical analgesic

White petrolatum - Skin protectant

Uses • temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

For external use only.

Allergy alert: do not use if you have a history 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

When using this product • do not get into eyes

Stop use and ask a physician if • conditions worsens • symptoms do not improve in 7 days • symptoms clear up and occur again within a few days • swelling, rash or fever develops • irritation, pain or redness persists or worsens

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

Directions

• squeeze tube to dispense • blend well until green tint disappears • rub in gently

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 physician

Other information • do not use if the package is torn, cut or otherwise damaged • store at 15-30ºC (59-86º) 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 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com

Orajel

Instan Pain Relief

FOR COLD SORES

MOISTURELOCK FORMULA

Helps Speed Healing

Treats 6 Symptoms:

1 Pain

2 Itching

3 Redness

4 Scabbing

5 Cracking

6 Dryness

PLUS

Helps Minimize Appearance of Cold Sores

Topical Anesthetic/Topical

Analgesic/Skin Protectant

NET WT 0.105 OZ (3g)

ORAJEL COLD SORE MOISTURELOCK 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-761
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
ALLANTOIN (ALLANTOIN) ALLANTOIN5 mg  in 1 g
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)30 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 LEAF 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 5 
PROPYLENE GLYCOL 
.ALPHA.-TOCOPHEROL ACETATE 
VITAMIN A PALMITATE 
CORN OIL 
CHOLECALCIFEROL 
FERRIC OXIDE RED 
FD&C BLUE NO. 1 
TOCOPHEROL 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-761-011 TUBE in 1 CARTON
13 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2016
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Accupac071609663manufacture(10237-761)

 
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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