EPHIDERM SPOT TREATMENT- salicylic acid lotion 
KANTIAN SKINCARE, LLC

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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Active Ingredient:

Salicylic acid 1.0%

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 – 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)

Principal Display Panel – Tube Label
EPHIDERM SPOT TREATMENT 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57524-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1.0 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57524-013-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358B01/10/2013
Labeler - KANTIAN SKINCARE, LLC (078436984)
Establishment
NameAddressID/FEIBusiness Operations
Kantian Skincare, LLC078436984LABEL(57524-013)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc010297942MANUFACTURE(57524-013)

Revised: 4/2013
Document Id: 47dba2cd-a67e-468e-a073-b31ab7057f6e
Set id: 1c31c336-d659-4865-9515-25b9f387edbc
Version: 1
Effective Time: 20130404
 
KANTIAN SKINCARE, LLC