Eptex Controlled Release Acne Wash - Benzoyl Peroxide 4.5%

Eptex 4.5% by

Drug Labeling and Warnings

Eptex 4.5% by is a Otc medication manufactured, distributed, or labeled by PuraCap Pharmaceutical LLC, SALVONA TECHNOLOGIES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EPTEX 4.5%- benzoyl peroxide liquid, extended release 
PuraCap Pharmaceutical LLC

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.

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Eptex Controlled Release Acne Wash - Benzoyl Peroxide 4.5%

Active ingredient

Benzoyl Peroxide 4.5%

Purpose

Acne Treatment

Uses

For the treatment of acne

Warnings

​For external use only

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

​When using this product

  • skin irritation and dryness is more likely to occur if you use another topical 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 hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibl by swelling. Irritation may be reduced by using the product less drequently or in a lower concentration

​Stop use and ask a doctor

  • ​if irritation becomes severe.

Keep out of reach of children.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

​Directions

  • clean the skin thoroughly before applying this product
  • cover the entire effected area with a thin layer, massage gently and rinse thoroughly
  • because excessubg drying of the skin may occur, statr 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 peeling 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 product and ask a doctor

​Other information

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).

Inactive ingredients

Aqua/Water, Cocomidopropyl Betaine, Sodium C14-C16 Olefin Sulfonate, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Dipropylene Glycol, 1,3-Butylene Glycol, Butyrospermum Parkii Butter, Xanthan Gum, Euphorbia Cerifera Wax, Hydroxypropyl methylcellulose, Phenoxyethanol, Ethylhexylglycerin, PEG-11 Avocado Glycerides, Hydrolyzed Corn Starch Hydroxypropyl Bispalmitamide MEA, Cholesterol
Isomerized Safflower Acid, Palmitic Acid, Hydrated Silica, Zea Mays Starch, Hydrolyzed Corn Starch Octenylsuccinate

Questions or comments?

Call: ​866-770-3027

Package/Label Printical Display Panel - Carton

eptex 4.5% Controlled Release Acne Wash Benzoyl Peroxide 4.5%

PROFESSIONAL DISPENSED ONLY

Epictex is a tradmark of PuraCap® Pharmaceutical LLC Piscataway, NJ 08854

MultiSal is a trademark of Salvona Technologies LLC.

Distributed by PuraCap® Pharmaceutical LLC Piscataway, NJ 08854

Made in USA

www.eptexskincare.com

EW45-01

Carton Label

EPTEX 4.5% 
benzoyl peroxide liquid, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51013-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE4.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SHEA BUTTER (UNII: K49155WL9Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PEG-11 AVOCADO GLYCERIDES (UNII: YLY4A64409)  
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)  
ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)  
PALMITIC ACID (UNII: 2V16EO95H1)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
STARCH, CORN (UNII: O8232NY3SJ)  
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51013-801-71177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/23/201610/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/23/201610/01/2018
Labeler - PuraCap Pharmaceutical LLC (962106329)
Registrant - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
SALVONA TECHNOLOGIES LLC113437946manufacture(51013-801)

Revised: 12/2019
 
PuraCap Pharmaceutical LLC