Otc - Active Ingredient
Ingredient: Benzocaine 20% Purpose: Local Anesthetic
Dermoplast Post Partum Aerosol, Spray
FDA Label NDC 16864-640
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advantice Health, Llc for the product Dermoplast Post Partum (NDC 16864-640). 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 otc - active ingredient, dosage & administration, inactive ingredient, warnings, indications & usage, otc - keep out of reach of children, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting and blotting with an appropriate cleansing pad.
• Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
• Hold can 6 to 12 inches away from affected area. Direct the spray nozzle towards the skin and press the button to activate spray.
• Apply to the affected area up to 6 times daily.
• Children under 12 years of age: consult a doctor.
Inactive Ingredient
acetylated lanolin alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben USP, PEG-400 monolaurate, menthol, polysorbate 85
Warnings
For external use only
Flammable: do not use near heat, flame, or fire or while smoking
When using this product:
• Do not exceed the recommended daily dosage unless directed by a doctor.
• Do not get into eyes.
• Do not put this product into the rectum by using fingers or any mechanical device or applicator.
• Intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal.
• Do not puncture or incinerate. Contents under pressure.
• Do not store at temperatures above 120°F.
Stop use and ask a doctor if:
• Condition worsens or does not improve within 7 days.
• Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
• In case of bleeding, consult a doctor promptly
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
• helps relieve the itching and discomfort in the perianal area. • for temporary relief of pain, soreness and burning.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Purpose
Local Anesthetic
Package Label.Principal Display Panel
Can (Cm747)
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