Otc - Active Ingredient
SALICYLIC ACID1.08%
Phofay Acne Spot Treatment Cream
FDA Label NDC 85161-132
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Longway Technology(guangzhou) Co., Ltd. for the product Phofay Acne Spot Treatment Cream (NDC 85161-132). 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 otc - active ingredient, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, other safety information, otc - purpose, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
lf Swallowed, Get Medica Help or Contact a Poison Control Center right away
Warnings
For external use only
When using this product
skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. lf irritation occurs, only use one topical acne medication at a time.
Dosage & Administration
Directions
clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
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 Ingredient
Water, Butylene Glycol, Caprylic/Capric Triglyceride,Cetyl Ethylhexanoate, Propylene Glycol, Dimethicone Cetearyl Alcohol, C14-22 Alcohols, Glyceryl Stearate，Niacinamide, Betaine,PEG-100 Stearate, 1,2-Hexanediol,Hydroxyacetophenone, Sodium Hydroxide, PEG-40 Hydrogenated Castor Oil, C12-20 Alkyl Glucoside,Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum,Centella Asiatica Root Extract, Menthol, Dipotassium Glycyrrhizate, Citric Acid, lron Oxides (Cl 77492)
Other Safety Information
protect the product in this container from excessive
heat and direct sun
Otc - Purpose
Acne treatment
Indications & Usage
For the treatment of acne
Reduces the number of acne blemishes
Helps prevent the development of new acne pimples
Package Label.Principal Display Panel
Phofay Acne Spot Treatment Cream (01)
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