Medicated Acne Shower
FDA Label NDC 58876-108

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr Lin Skincare for the product Medicated Acne Shower (NDC 58876-108). 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, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

SALICYLIC ACID 2%

Otc - Purpose

PURPOSE

ACNE TREATMENT

Indications & Usage

USE

FOR THE TREATMENT OF ACNE

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - Do Not Use

DO NOT USE IF YOU HAVE  KNOWN ALLERGY TO SALICYLIC ACID OR ASPERIN.

Otc - Ask Doctor/Pharmacist

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF TH SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Otc - Stop Use

STOP USE ND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

  • AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Dosage & Administration

DIRECTIONS

  • USE MORNING AND NIGHT.
  • WET AREA TO BE CLEANSED.
  • APPLY ACNE TREATMENT ND GENTLY MASSAGE AREA FOR 1-2 MINUTES..
  • RINSE THOROUGHLY AND PAT DRY.
  • RINSE THOROUGHLY WITH WATER..

Inactive Ingredient

INACTIVE INGREDIENTS

WATER, SODIUM C14-16 OLEFIN SULFONATE, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, SODIUM LAURYL SULFOACETATE, PEG-150 DISTEARATE, PHENOXYETHANOL, METHYLISOTHIAZOLINONE, AMINOMETHYL PROPANOL, SODIUM CHLORIDE, GLYCERIN, ALLANTOIN

Otc - Questions

QUESTIONS OR COMMENTS? 1-877-445-4624

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