Label: BIO-SCRIPTIVES REPIDERM- benzoly peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60608-012-00 - Packager: BioChemics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 10, 2015
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- Active Ingredients
- Purpose
- Uses
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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
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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.
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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.
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INGREDIENTS AND APPEARANCE
BIO-SCRIPTIVES REPIDERM
benzoly peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60608-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 3.29 g in 56 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) COLEUS FORSKOHLII ROOT OIL (UNII: 5NXR7DJ9WO) LEMON OIL (UNII: I9GRO824LL) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) EUCALYPTUS OIL (UNII: 2R04ONI662) ROSEMARY OIL (UNII: 8LGU7VM393) SODIUM CHLORIDE (UNII: 451W47IQ8X) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) AZADIRACHTIN (UNII: O4U1SAF85H) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) CHAMOMILE (UNII: FGL3685T2X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) EDETATE SODIUM (UNII: MP1J8420LU) METHYL NICOTINATE (UNII: 7B1AVU9DJN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60608-012-00 56 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/24/2010 Labeler - BioChemics, Inc. (802946426) Registrant - Coastal Products Company (782445688) Establishment Name Address ID/FEI Business Operations Coastal Products Company 782445688 manufacture(60608-012)