Otc - Active Ingredient
Active ingredient
Purpose
Salicylic Acid(0.5%)..Acne treatment
Derm Acne Solution Gel
FDA Label NDC 87512-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yantai Aien Biotechnology Co., Ltd. for the product Derm Acne Solution Gel (NDC 87512-003). 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 - purpose, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, indications & usage, 87512-003-01 derm acne solution gel 10g, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For the treatment of acne
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrenIf swallowed, get medical help orcontact a Poison Control Centerright away.
Warnings
WarningsFor external use only
When using this productSkin irritation and dryness is
more likely to occur if you use
another topical acne medication
at the same time. If irritation
occurs, only use one topical acneat a time.
Avoid contact with eyes. If
contact occurs, flush thoroughly
with water.
Dosage & Administration
Cover the entire affected areawith a thin layer one to threetimes daily. Because excessivedrying of the skin may occur, ifneeded or as directed by a doctor.Start with one application daily,then gradually increase to two orthree times daily if needed or asdirected by a doctor.If bothersome dryness of peelingoccurs, reduce application to onea day or every other day.
Inactive Ingredient
Inactive ingredients
Acid, Propylene Glycol,
Polyhexanide, Riboflavin, Hyaluronic
Dimethicone, 3-O-Ethyl Ascorbic
Acid, Allantoin, Marine Collagen,
Carbomer Homopolymer, Trolamine,
Water
Indications & Usage
Directions
Cleanse the skin thoroughlybefore applying this product.Cover the entire affected areawith a thin layer one to threetimes daily. Because excessivedrying of the skin may occur, ifneeded or as directed by a doctor.Start with one application daily,then gradually increase to two orthree times daily if needed or asdirected by a doctor.If bothersome dryness of peeling
occurs, reduce application to one
a day or every other day.
* Please review the disclaimer below.
