Active Ingredient
Dexamethasone 0.075%
Seacall Dexamethasone Ointment. Ointment
FDA Label NDC 76986-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Seacall Dexamethasone Ointment. (NDC 76986-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, keep oot of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Relief of dermatitis itching.
Use
Used for pruritus, neurodermatitis, contact dermatitis, seborrheic dermatitis, chronic eczema.
Warnings
For external use only.
Not for infants.
Use with caution in pregnant and lactating women.
Prohibited for those who are allergic to this product.
Allergic persons should be cautious.
Prohibit the use when the properties of the product have changed.
Should not be used on a large scale and for a long time.
Do Not Use
If the affected area has been broken, pus or obvious oozing or viral infections (such as herpes, blisters).
When Using
Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
Stop Use
Ask a doctor if any burning sensation, redness, or swelling at the site of application or bacterial or fungal infections occurs or if symptoms are not relieved after 1 week of use.
Keep Oot Of Reach Of Children
Children must be used under adult supervision. In case of accidental ingestion, get medical help or contact a poison control center immediately.
Directions
1-2 times a day, take a small amount of application on the affected area and gently rub for a moment.
Other Information
If you are using other drugs, please consult your physician or pharmacist before using this product.
Athletes should use it with caution.
Sealed, stored in a cool place.
Inactive Ingredients
Mineral Oil, Zinc Oxide, Beeswax, Copernicia Cerifera (Carnauba) Wax, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Bisabolol, Octyldodecanol, Polyglyceryl-10 Dioleate, Borneol, Echium Plantagineum Seed Oil, Farnesol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Zingiber Officinale (Ginger) Root Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Tocopherol.
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