EPHIDERM SPOT TREATMENT- salicylic acid lotion

epHiderm Spot Treatment by

Drug Labeling and Warnings

epHiderm Spot Treatment by is a Otc medication manufactured, distributed, or labeled by KANTIAN SKINCARE, LLC, Kantian Skincare, LLC, PhytogenX, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Salicylic acid 1.0%

PURPOSE

Uses:

Treats and helps prevent acne blemishes

Warnings:

For external use only. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Using other topical acne medications at the same time or right after use of this product may increase skin dryness or irritation. Avoid doing this, unless directed by a doctor. Avoid unnecessary sun exposure and use sunscreen. Allow epHiderm Spot Treatment to dry, then follow the sunscreen directions. Do not use this product if you have sensitive skin or if you are sensitive to AHAs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use this product on infants under 6 months of age.

Directions:

Apply a thin layer to the affected area, In the morning and evening. For best results, apply epHiderm Synergyzer after epHiderm Spot Treatment. Wash hands thoroughly after application.

Inactive Ingredients:

Water, Isopropyl alcohol, Propylene glycol, Hydroxyethylcellulose, Mandelic acid, Methyloxirane, Oxirane, Sodium benzoate, FD&C Blue #1

Distributed by: Kantian Skincare, LLC.
Smithtown, NY, 11787. Made in USA ©2012.

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Tube Label

epHiderm

ANTI-ACNE SOLUTION
SPOT TREATMENT

Eliminates acne causing bacteria
Clears acne pimples and blackheads quickly
Gentle enough for everyday use

Dermatologist Recommended

MADE IN USA

NET WT. 1 OZ (28g)

INGREDIENTS AND APPEARANCE

EPHIDERM SPOT TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57524-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	1.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Isopropyl Alcohol (UNII: ND2M416302)
Propylene Glycol (UNII: 6DC9Q167V3)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
Mandelic Acid (UNII: NH496X0UJX)
Sodium Benzoate (UNII: OJ245FE5EU)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
Propylene Oxide (UNII: Y4Y7NYD4BK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57524-013-01	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358B	01/10/2013

Labeler - KANTIAN SKINCARE, LLC (078436984)

Establishment
Name	Address	ID/FEI	Business Operations
Kantian Skincare, LLC		078436984	LABEL(57524-013)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc		010297942	MANUFACTURE(57524-013)