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| Product NDC Code | 10237-761 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Orajel cold sore moisturelock |
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| Type | Brand | ||||||||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Skin Barrier Activity [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | CREAM | ||||||||||||
| RxCUI drug identifier | 2257305 | ||||||||||||
| Application Number | part356 | ||||||||||||
| Labeler Name | Church & Dwight Co., Inc. | ||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Allantoin 0.5% Benzocaine 20% Camphor 3% Dimethicone 2% Menthol 1% White petrolatum 64%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters
Purpose
Information about the drug product’s indications for use.Allantoin - Skin protectant Benzocaine - Topical anesthetic Camphor - Topical analgesic Dimethicone - Skin protectant Menthol - Topical analgesic White petrolatum - Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Orajel Cold Sore Moisturelock Benzocaine 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 BENZOCAINE BENZOCAINE ALLANTOIN ALLANTOIN CAMPHOR (NATURAL) CAMPHOR (NATURAL) DIMETHICONE DIMETHICONE MENTHOL MENTHOL PETROLATUM PETROLATUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • more than directed • for more than 7 days unless directed by a physician
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • do not get into eyes
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API