Label: DUAL-SHAVE 2 IN 1- benzoyl peroxide lotion

  • 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 November 4, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    BENZOYL PEROXIDE 5%

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  • PURPOSE

    ACNE TREATMENT

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  • USE

    FOR THE TREATMENT OF ACNE AND TO PREVENT SKIN BLEMISHES WHEN SHAVING.

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  • WARNINGS

    FOR EXTERNAL USE ONLY.

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  • WHEN USING

    WHEN USING THIS PRODUCT: SKIN DRYNESS AND IRRITATION IS MORE LIKELY TO OCCUR WHEN USED WITH ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION DOES OCCUR, USE LESS ACNE-FIGHTING MEDICATION. ALWAYS TRY TO AVOID ADDED UNNECESSARY SUN EXPOSURE AND ALWAYS USE SUNSCREEN IF POSSIBLE. AVOID CONTACT WITH EYES, LIPS AN MOUTH. IF CONTACT OCCURS FLUSH THOROUGHLY WITH WATER. SKIN IRRITATION IS DEFINED BY SYMPTOMS SUCH AS BURNING, ITCHING, PEELING, SWELLING OR REDNESS. IF BY CHANCE IRRITATION DOES OCCUR, REDUCE IRRITATION BY USING A SMALLER AMOUNT OR BY USING THIS PRODUCT LESS OFTEN.

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  • DO NOT USE

    WHEN NOT TO USE THIS PRODUCT: IF YOU HAVE EXTREMELY SENSITIVE SKIN OR ARE HIGHLY SENSITIVE TO BENZOYL PEROXIDE.

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  • STOP USE

    STOP USE AND ASK A DOCTOR IF: IRRITATION BECOMES ACUTE.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN: IF SWALLOWED, SEEK IMMEDIATE MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER NEAR YOU.

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  • DIRECTIONS

    DUAL-SHAVE IS UNLIKE OTHER SHAVING GELS AND FOAMS! THIS PRODUCT IS BEST USED WHEN SHAVING OR WASHING ONES FACE IN THE SHOWER, BUT CAN ALSO BE USED IN TRADITIONAL FASHIONS AS WELL. IT'S ALWAYS BEST TO WET AREA WITH WARM WATER TO OPEN THE PORES OF THE SKIN.

    TO SHAVE: PUT A LARGE QUARTER-SIZED AMOUNT ONTO CLEAN FINGERTIPS. MAKE SURE A NICE LAYER IS COVERING THE ENTIRE AREA TO BE SHAVED AND ADD MORE IF NEEDED. PROCEED TO SHAVE. FOR LESS IRRITATION REMEMBER TO ALWAYS SHAVE IN THE SAME DIRECTION THAT THE HAIR-FOLLICLE IS GROWING. ONCE THE ENTIRE AREA IS SHAVED, RINSE THOROUGHLY. IT'S ALWAYS BEST TO RINSE FACE WITH COLD WATER TO CLOSE PORES. IT'S VERY COMMON TO FEEL A TINGLY SENSATION... THIS MEANS DUAL-SHAVE IS WORKING!

    TO USE AS AN ANTI-ACNE FACIAL WASH: PUT A QUARTER-SIZED AMOUNT ONTO CLEAN FINGERTIPS. MAKE SURE A NICE LAYER IS COVERING THE ENTIRE AREA TO BE CLEANED AND ADD MORE IF NEEDED. APPLY ONTO FACE IN A CIRCULAR MOTION. ONCE ENTIRE AREA IS COVERED AND SATURATED THEN RINSE WELL WITH COLD WATER TO CLOSE PORES.

    NO NEED TO EVER FOLLOW THROUGH TWICE FOR SHAVING OR WASHING YOUR FACE. AFTER USING DUAL-SHAVE, THIS PRODUCT WILL LEAVE YOUR FACE FEELING CRISP AND CLEAN, WITH NO STRONG SCENT LEFT BEHIND.

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  • OTHER INFORMATION

    STORE AT 20°C TO 25°C (68°F - 77°F).

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  • INACTIVE INGREDIENTS

    WATER, MYRISTIC ACID, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, STEARIC ACID, ACRYLATES COPOLYMER, POTASSIUM HYDROXIDE, LAURIC ACID, GLYCERIN, GLYCOL DISTEARATE, LAURAMINE OXIDE, SODIUM METHYL COCOYL TAURATE, PHENOXYETHANOL, BENZOIC ACID, ETHYLHEXYLGLYCERIN, GLYCERETH-2 COCOATE, FRAGRANCE, DISODIUM EDTA, EUCALYPTUS GLOBULUS LEAF EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF EXTRACT, AVENA SATIVA (OAT) KERNEL EXTRACT, ALLANTOIN, GOAT MILK

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  • QUESTIONS?

    CALL DIRECT +1 (310) 461-1980 OR VISIT WWW.DUAL-SHAVE.COM

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  • INGREDIENTS AND APPEARANCE
    DUAL-SHAVE 2 IN 1 
    benzoyl peroxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71295-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GOAT MILK (UNII: XE5K5I4RP7)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71295-101-11 198 g in 1 TUBE; Type 0: Not a Combination Product 03/06/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 03/06/2017
    Labeler - DUAL-SHAVE LLC (615875338)
    Establishment
    Name Address ID/FEI Business Operations
    Health Specialty 794053863 manufacture(71295-101)
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