DUAL-SHAVE 2 IN 1- benzoyl peroxide lotion

DUAL-SHAVE 2 IN 1 by

Drug Labeling and Warnings

DUAL-SHAVE 2 IN 1 by is a Otc medication manufactured, distributed, or labeled by DUAL-SHAVE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

PURPOSE

ACNE TREATMENT

USE

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

WARNINGS

FOR EXTERNAL USE ONLY.

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.

DO NOT USE

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

STOP USE

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

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.

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.

OTHER INFORMATION

STORE AT 20°C TO 25°C (68°F - 77°F).

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

QUESTIONS?

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

PRINCIPAL DISPLAY PANEL

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)