EPOCH- salicylic acid gel

Epoch by

Drug Labeling and Warnings

Epoch by is a Otc medication manufactured, distributed, or labeled by NSE Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid (2%)

Purpose

Acne medication

Use

For the treatment of acne.

Warnings

• For external use only. Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

• Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Cleanse skin thoroughly before applying.
• Cover the affected area with a thin layer one to three times a day.
• 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.

Inactive Ingredients

Water (Aqua), PEG-32, PVM/MA Decadiene Crosspolymer, Coix Lacryma-Jobi Ma-yuen Seed Extract, Achillea Millefolium Extract, Arctium Lappa Root Extract, Butylene Glycol, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Alpha-Glucan Oligosaccharide, Sodium Hydroxide, Disodium EDTA, Fragrance (Parfum).

Questions?

1-888-742-7626

PRINCIPAL DISPLAY PANEL - 15 ml Tube Label

epoch ®

Acne Medication

Blemish Treatment

Epoch® Acne Medication Blemish Treatment helps diminish
the discomfort of breakouts with unique ethnobotanicals—Job's tears,
used historically in Asia to calm the skin; yarrow, used for centuries
to help soothe the skin; burdock, which helps clear up troubled
complexions; and skin-soothing chamomile extract. Also contains the
proven pore-clearing acne medicine, salicylic acid. Naturally
fragrance-free, the formula is friendly to sensitive skin.

15 ml e (0.5 fl. oz.)

INGREDIENTS AND APPEARANCE

EPOCH 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62839-1084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
Coix Lacryma-Jobi Var. Ma-Yuen Seed (UNII: 8DW238I7ZI)
Achillea Millefolium (UNII: 2FXJ6SW4PK)
Arctium Lappa Root (UNII: 597E9BI3Z3)
Butylene Glycol (UNII: 3XUS85K0RA)
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-1084-5	1 in 1 POUCH
1		15 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	06/10/2001

Labeler - NSE Products, Inc. (966817975)