Active Ingredient:
Salicylic acid 1.0%
Ephiderm Spot Treatment
FDA Label NDC 57524-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kantian Skincare, Llc for the product Ephiderm Spot Treatment (NDC 57524-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient:, uses:, warnings:, otc - keep out of reach of children, directions:, inactive ingredients:, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Keep Out Of Reach Of Children
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.
Package Label.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)
Principal Display Panel – Tube Label (Eph01 0000 01)
* Please review the disclaimer below.
