Eptex Controlled Release Acne Relief Lotion - Salicylic Acid 2%

Eptex 2% by

Drug Labeling and Warnings

Eptex 2% 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 2%- salicylic acid 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 Relief Lotion - Salicylic Acid 2%

Active ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Use

For the treatement of acne

Warnings

​For external use only

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.

​Stop use and ask a doctor if irritation occurs

Keep out of the reach of children

​Keep out of the reach of children.

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

Directions

  • clean the skin thoroughly before appying this product
  • cover the entire affected area with a thin 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 peeling occurs, reduce application to once a day or every other day

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, Cocamidopropyl Dimethyl Amine, C12-C15 Alkyl Benzoate, Glyceryl stearate, Glycerin, Cetyl Alcohol, Stearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, PEG-100 Stearate, Butyrospermum Parkii (Shea Butter), Vitis Vinifera (Grape) Seed Oil, Dimethicone, Polysorbate 80, Phenoxyethanol, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Hydrolyzed Corn Starch, Hyaluronic Acid, Panthenol, Hydroxypropyl Bispalmitamide MEA, Palmitic Acid, Cholesterol, Isomerized Safflower Acid, Euphorbia Cerifera Wax, Hydrated Silica, Butyrospermum Parkii (Shea Butter), Ascorbic Acid, Benzalkonium Chloride, Glycin Soja (Soybean) Oil, Chamomilla Recutita Flower Extract, Isomerized Safflower Acid, Palmitoyl Tripepride-5, Camellia Sinesis Leaf Extract, Maltodextrin, Beeswax, Zea Mays Starch, Hydrolyzed Corn Starch, Octenylsuccinate, Kaolin, Zinc Sulfate, Fecus Vesiculosus Extract

Questions or comments?

Call: ​866-770-3027

Package/Label Printical Display Panel - Carton

eptex 2% Controlled Release Acne Relief Lotion Salicylic Acid 2%

PROFESSIONAL DISPENSED ONLY

Eptex 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

EL02-01

Carton Label

EPTEX 2% 
salicylic acid liquid, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51013-802
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SHEA BUTTER (UNII: K49155WL9Y)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYALURONIC ACID (UNII: S270N0TRQY)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)  
PALMITIC ACID (UNII: 2V16EO95H1)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SOYBEAN OIL (UNII: 241ATL177A)  
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
KAOLIN (UNII: 24H4NWX5CO)  
ZINC SULFATE (UNII: 89DS0H96TB)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51013-802-70118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/23/201611/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/23/201611/20/2018
Labeler - PuraCap Pharmaceutical LLC (962106329)
Registrant - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
SALVONA TECHNOLOGIES LLC113437946manufacture(51013-802)

Revised: 12/2019
 
PuraCap Pharmaceutical LLC