Clarifying Pressed Powder
FDA Label NDC 76354-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J. A. Cosmetics U.s. Inc for the product Clarifying Pressed Powder (NDC 76354-201). 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 - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredient:

SALICYLC ACID 1%

Otc - Purpose

Purpose:

ACNE TRATMENT

Indications & Usage

Uses:

  • ​FOR THE TREATMENT OF ACNE
  • HELPS PREVENT NEW ACNE BLEMISHES

Warnings

Warning:

For external use only

Otc - When Using

When Using This Product

  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
  • USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Otc - Ask Doctor

Stop use and ask a doctor if

  • rash occurs.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Dosage & Administration

Directions:

  • CLEANSETHE SKIN THOROUGHLY BEFORE APPLYING MEDICTION.
    COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY. BEACAUSE EXCESSIVE DRYING OF 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

Inactive Ingredient:

TALC, MICA, MAGNESIUM STEARATE, ETHYLHEXYL PALMITATE, PARAFFINUM LIQUIDUM (MINERAL OIL), POLYBUTENE, SODIUM DEHYDROACETATE, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE (PARFUM)

May Contain: TITANUM DIOXIDE (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

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