EPIONCE PURIFYING SPOT GEL- sulfur gel

Epionce Purifying Spot Gel by

Drug Labeling and Warnings

Epionce Purifying Spot Gel by is a Otc medication manufactured, distributed, or labeled by Episciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Sulfur 3.3%

Purpose

Acne Treatment

Use

• For the treatment 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 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

• clean the skin thoroughly before applying this product
• cover 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 gradulally 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EPIONCE PURIFYING SPOT GEL 
sulfur gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42673-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.033 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42673-007-01	1 in 1 BOX	10/02/2018
1	NDC: 42673-007-00	10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/02/2018

Labeler - Episciences, Inc. (144733040)

Registrant - Episciences, Inc. (144733040)

Establishment
Name	Address	ID/FEI	Business Operations
Episciences, Inc.		144733040	manufacture(42673-007)