Let Me Clarify
FDA Label NDC 49520-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mybody for the product Let Me Clarify (NDC 49520-103). 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 - when using, 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 INGREDIENTS

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 VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

Otc - Ask Doctor/Pharmacist

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

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

Otc - When Using

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.
  • KEEP AWAY FROM LIPS AND MOUTH.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

DIRECTIONS

  • USE AM/PM. AFTER CLEANSING, GENTLY APPLY TO FACE OR AFFECTED AREAS.
  • BECAUSE EXCESSIVE DRYING OF THE FACE MAY OCCUR, START WITH ONE APPLICATION 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.

Other Safety Information

OTHER INFORMATION

* AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

Inactive Ingredient

INACTIVE INGREDIENTS: WATER, BUTYLENE GLYCOL, GLYCOLIC ACID, POLYQUATERNIUM 10, EUCALYPTUS GLOBULUS OIL, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ACETYL CARBOXYMETHYL COCOYL GLYCINE, MYRISTOYL TETRAPEPTIDE-13, HYDROXYPHENYL PROPAMIDOBENZOIC ACID, PENTYLENE GLYCOL, POTASSIUM HYDROXIDE.

Package Label.Principal Display Panel

Let-me-clarify_drug-facts-box (Let Me Clarify Drug Facts Box)

Let-me-clarify_drug-facts-box (Let Me Clarify Drug Facts Box)

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