Otc - Active Ingredient
Active Ingredient; Benzoyl Peroxide 2.5% (w/w)
Relovox
FDA Label NDC 51350-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Transdermal Corp for the product Relovox (NDC 51350-005). 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, otc - purpose, indications & usage, otc - keep out of reach of children, inactive ingredient, otc - do not use, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel. Children under 2 years of age, consult your doctor
Otc - Purpose
Use for the management of acne and pimples and acne spots removal.
Indications & Usage
Indicated and use for the management of acne and removal of the acne spots, Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel.Children under 2 years of age, consult your doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children, store in a cool dry place at room temperature.
Inactive Ingredient
Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, ethyl alcohol, staeric acid, carbomer, sodium hydroxide, cocamidopropyl betain, sodium lauryl sulfate, castor oil,glycolic acid, salicylic acid, cocoa butter, vitamin E, vitamin A, grape seeds oil.
Otc - Do Not Use
• Ask your doctor if you using other acne medications• Do not use if you are allergic to Benzoyl Peroxide• Do not use in or near the eyes• Do not use in large amount particularly over the raw surfaces or blistersStop use and Ask Doctors if• Allergic reactions occurs• Condition worsen and does not improve• Excessive dryness and peeling of skin occurs• itching, redness, burning , swelling or other symptoms occurs• Keep both used and unused medicine out of the reach of children or pets• If swallowed get medical attention right away Call your doctor immediately.
Warnings
• Do not use in or near the eyes• Do not use in large amount particularly over the raw surfaces or blistersStop use and Ask Doctors if• Allergic reactions occurs• Condition worsen and does not improve
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