EPIONCE PURIFYING SPOT GEL- sulfur gel 
Episciences, Inc.

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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Epionce Purifying Spot Gel

Active ingredients

Sulfur 3.3%

Purpose

Acne Treatment

Use

Warnings

For external use only

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, use only one topical acne medication at a time
  • apply only to areas with acne
  • rinse right away with water if it gets in eyes.

Do not use on

  • broken skin
  • large areas of skin

Stop use and ask a doctor

  • if skin irritation occurs or gets worse

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Azelaic Acid, Butylene Glycol, Caprylyl Glycol, Coconut Oil, Ethylhexylglycerin, Glycerin, Helianthus Annuus Flowering Top, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%), Levomenthol, Medium-Chain Triglycerides, Orange Oil, Paprika, Phenoxyethanol, Pyrithione Zinc, Quercetin, Resorcinol Monoacetate, Rice Bran, Rosemary, Safflower Oil, Spearmint Oil, Sulfur, Tocopherol, Water

Questions?

Call toll free 1-866-374-6623

Epionce Purifying Spot Gel Principal Display Panel

EPIONCE PURIFYING SPOT GEL 
sulfur gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42673-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.033 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
RICE BRAN (UNII: R60QEP13IC)  
ROSEMARY (UNII: IJ67X351P9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ORANGE OIL (UNII: AKN3KSD11B)  
PAPRIKA (UNII: X72Z47861V)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PYRITHIONE ZINC (UNII: R953O2RHZ5)  
AZELAIC ACID (UNII: F2VW3D43YT)  
GLYCERIN (UNII: PDC6A3C0OX)  
QUERCETIN (UNII: 9IKM0I5T1E)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
RESORCINOL MONOACETATE (UNII: YL6O37RD1S)  
SPEARMINT OIL (UNII: C3M81465G5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42673-007-011 in 1 BOX10/02/201805/31/2024
1NDC:42673-007-0010 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/02/201805/31/2024
Labeler - Episciences, Inc. (144733040)
Establishment
NameAddressID/FEIBusiness Operations
Episciences, Inc.144733040manufacture(42673-007)

Revised: 6/2022
Document Id: e08e64bb-bd7f-8949-e053-2995a90aa70a
Set id: 7c721655-8f46-1404-e053-2a91aa0a6b26
Version: 7
Effective Time: 20220603
 
Episciences, Inc.