Active Ingredient
Benzoyl Peroxide 5%
Theraspec
FDA Label NDC 52205-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Salient Labs, Llc for the product Theraspec (NDC 52205-003). 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, otc - purpose, use, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne medication
Use
for the treatment of acne
Warnings
For external use only
Otc - Do Not Use
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide
Otc - When Using
When using this product
- keep away from eyes, lips and mouth
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with hair, dyed fabric, including carpet and clothing which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. lf irritation becomes severe, discontinue use: if irritation still continues, consult a doctor.
- using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Dosage & Administration
Directions Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Recommended for use twice daily.
Inactive Ingredient
Inactive Ingredients Acrylates Copolymer, Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Ceteareth-20, Dehydroacetic Acid, Hydrolyzed Jojoba Esters, lsopentyldiol, Jojoba Esters, Sodium Cocyl lsethionate.
Package Label.Principal Display Panel
TheraSpec
Acne Cleanser
Principal Display Panel
221 ml
NDC: 52205-003-00
Label (Asttheraspec5bpowrap)
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