Label: EPOCH- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62839-1084-5 - Packager: NSE Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 24, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
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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.
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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).
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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.)
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INGREDIENTS AND APPEARANCE
EPOCH
salicylic acid gelProduct 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)