ORAJEL COLD SORE MOISTURELOCK- benzocaine 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.

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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)

FT_OJBC-99882-04

BK_OJBC-99882-04

ORAJEL COLD SORE MOISTURELOCK 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-761
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)30 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM640 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PRUNELLA VULGARIS LEAF (UNII: 2LW0610U4O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CORN OIL (UNII: 8470G57WFM)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-761-011 in 1 CARTON07/01/2016
13 g in 1 TUBE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Accupac071609663manufacture(10237-761)

Revised: 1/2022
Document Id: d5785386-38bf-06d4-e053-2995a90abe5a
Set id: 3761c7b3-053b-0f50-e054-00144ff88e88
Version: 7
Effective Time: 20220113
 
Church & Dwight Co., Inc.