Active Ingredients
4.4% Benzoyl Peroxide
Bio-scriptives Repiderm
FDA Label NDC 60608-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biochemics, Inc. for the product Bio-scriptives Repiderm (NDC 60608-012). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Uses
■ for the treatment of acne
Warnings
For external use only
Do not use if you
■ have very sensative skin
■ if you are sensative to benzoly peroxide
When using this product
■ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. ■ avoid unnecessary sun exposure and use a sunscreen. ■ avoid contact with eyes, lips, and mouth. ■ avoid contact with hair and dyed fabrics which may be bleached by this product. ■ skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequenly or in a lower concentration.
Stop use and ask a doctor if ■ irritation becomes severe
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ clean the skin thoroughly before applying this product ■ cover the entire affected area with a think layer one to three times daily ■ because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor ■ if bothersome dryness or peelinig occurs, reduce application to once a day or every other day ■ if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Inactive Ingredients
Distilled Water, Aloe, Propylene Glycol, Cetyl Alcohol, Glyceryl Monostearate, Arginine HCI, Dimethicone, Cyclomethicone, PEG-40 Hydrogenated Castor Oil, Coleus Forskohlii Oil, Lemon Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eucalyptus Oil, Rosmarius Officianalis (Rosemay) Leaf Oil, Sodium Chloride, Fragrance, Xanthan Gum, Allantoin, Calendula Officinalis Flower Extract, Algae Extract, Althaea Officianalis Root Extract, Echinacea Augustifolia Extract, Chamomile Extract, Melia Azadirachta See Oil, Methylisothiazolinone, Sodium EDTA, Methyl Nicotinate.
Otc - Questions
BioScriptives™
77 N. Washington Street
Boston, MA 02114
617-379-5676
Label
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