BIO-SCRIPTIVES REPIDERM- benzoly peroxide cream

Bio-Scriptives Repiderm by

Drug Labeling and Warnings

Bio-Scriptives Repiderm by is a Otc medication manufactured, distributed, or labeled by BioChemics, Inc., Coastal Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

4.4% Benzoyl Peroxide

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

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.

QUESTIONS

BioScriptives™

77 N. Washington Street

Boston, MA 02114

617-379-5676

LABEL

INGREDIENTS AND APPEARANCE

BIO-SCRIPTIVES REPIDERM 
benzoly peroxide cream

Product 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)