ORAJEL FOR CODL SORES RELIEF AND CONCEALER- allantoin benzocaine camphor 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 Instant Pain Relief for Cold Sores

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

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.


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

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

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

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

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

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

Skin protectant and topical analgesic

MOISTURIZES to

HELP SPEED HEALING

NEW!

Orajel

Instant Pain Relief

FOR

COLD

SORES

medicated

brush

RELIEF AND

CONCEALER

GREEN TINT

HELPS CONCEAL REDNESS

NET WT 0.05 OZ (1.4g)

Card image

ORAJEL FOR CODL SORES RELIEF AND CONCEALER 
allantoin benzocaine camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-726
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)30 mg  in 1 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 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 (UNII: ID3IB81B1C)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CORN OIL (UNII: 8470G57WFM)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
IRON (UNII: E1UOL152H7)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-726-051 in 1 BLISTER PACK07/19/201001/31/2017
11.4 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/19/201001/31/2017
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Direct Merchantdising Inc.076693183manufacture(10237-726)

Revised: 12/2019
 
Church & Dwight Co., Inc.