Orajel for Cold Sores by Church & Dwight Co., Inc. Orajel for Cold Sores

Orajel for Cold Sores by

Drug Labeling and Warnings

Orajel for Cold Sores by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL FOR COLD SORES- 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 for Cold Sores

Active Ingredients

Benzocaine 20%

White petrolatum 74.44%

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

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

Warnings

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

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

Keep out of reach of children.

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

Directions

• cut open tube of tip on score mark
• Do not use if tip is cut prior to opening

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

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

PROTECTIVE SHIELD

STAYS in PLACE

cream

NEW!

Orajel

Instant Pain Relief

FOR COLD SORES

MOISTURIZING BARRIER

HELPS SPEED HEALING

SAFETY SEALED TUBE TIP

NET WT 0.21 OZ (5.9 g) TOPICAL ANALGESIC/SKIN PROTECTANT

ORAJEL FOR COLD SORES 
benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-750
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	744.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PRUNELLA VULGARIS (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-750-21	1 in 1 CARTON	07/27/2010	12/31/2019
1		5.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/27/2010	12/31/2019

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-750)

Revised: 1/2020

Document Id: 9ca78090-c599-3091-e053-2995a90a6232

34390-5

Set id: 9bb252f3-080b-4177-ab2e-10f7206c48ac

Version: 3

Effective Time: 20200121

 

Church & Dwight Co., Inc.