ORAJEL FOR COLD SORES DOUBLE MEDICATED, CREAM- benzocaine and white petrolatum 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 for Cold Sores Double Medicated, Cream

Benzocaine 20%

White petrolatum 73.64%

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

Topical anesthetic

Skin protectant

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

Warnings

For external use only

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy

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

Keep out of reach of children.

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

Directions

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

Children betweem 2 and 12 years of age: Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age: Do not use

Inactive ingredients cholecalciferol, mineral oil, phenoxyethanol (and) hydroxyacetophenone (and) caprylyl glycol (and) water, propylene glycol, prunella vulgaris leaf extract, retinyl palmitate (vitamin A palmitate), tocopherol, tocopherol acetate (vitamin E acetate), zea mays (corn) oil

#1

ORAL PAIN

RELIVER

BRAND

FOR ADULTS

2 Active

Ingredients

Orajel

Instant Pain Relief

FOR COLD SORES

Fast-Acting Cream

DOUBLE MEDICATED

Relieves Pain & Itching

Moisturizing Barrier Stays in Place

Paraben Free

TOPICAL ANESTHETIC/SKIN PROTECTANT

NET WT 0.125 OZ (3.5 g)

Label.jpg

ORAJEL FOR COLD SORES DOUBLE MEDICATED, CREAM 
benzocaine and white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-797
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM736.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PRUNELLA VULGARIS FLOWERING TOP (UNII: ID3IB81B1C)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
WATER (UNII: 059QF0KO0R)  
CORN OIL (UNII: 8470G57WFM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-797-121 in 1 CARTON01/18/2021
13.5 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 FINALpart35601/18/2021
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812MANUFACTURE(10237-797)

Revised: 1/2023
Document Id: 6a0df30a-700b-4f01-b60e-c79c4a4caf6b
Set id: b8699a40-8464-ca02-e053-2995a90a4260
Version: 3
Effective Time: 20230110
 
Church & Dwight Co., Inc.