FDA.reportPublic FDA data

LET ME CLARIFY

Manufacturer
mybody
Effective date
2013-12-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:38:04

Label at a glance#

ProductLET ME CLARIFY
Active ingredientSALICYLIC ACID
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

SALICYLIC ACID 2%

OTC - PURPOSE SECTION

PURPOSE

ACNE TREATMENT

INDICATIONS & USAGE SECTION

USE FOR THE TREATMENT OF ACNE

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

DO NOT USE * IF YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

OTC - ASK DOCTOR/PHARMACIST SECTION

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 SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

5-8 x 2_5ml Die-Line_LET ME CLARIFY_V3_10.24.115-8 x 2_5ml Die-Line_LET ME CLARIFY_V3_10.24.11Let-Me-Clarify_Drug-Facts-BoxLet-Me-Clarify_Drug-Facts-Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN6
346298salicylic acid 0.02 MG/MG Topical GelSCD6
346298salicylic acid 2 % Topical GelSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49520-103-112019-11-27C16284748780-19855e2a2-39f0-60a7-e053-dbdaa90a05bd8e36c36f-aa9e-4ae2-8dea-53d167e81a7f
49520-103-312019-11-27C16284748780-19855e2a2-39f0-60a7-e053-dbdaa90a05bd8e36c36f-aa9e-4ae2-8dea-53d167e81a7f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49520-103-11LET ME CLARIFY30 mL in 1 BOTTLEGEL306
49520-103-31LET ME CLARIFY5 mL in 1 TUBEGEL56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49520-103LET ME CLARIFY (SALICYLIC ACID) GEL [MYBODY]6Legacy NDC, 2 package rows20140106_8e36c36f-aa9e-4ae2-8dea-53d167e81a7f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ6
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ6
1,3-BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA6
ACETYL CARBOXYMETHYL COCOYL GLYCINEINACTIVE INGREDIENT3TNX4P92J36
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E66
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38S6
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H6
HYDROXYPHENYL PROPAMIDOBENZOIC ACIDINACTIVE INGREDIENT25KRT26H776
MYRISTOYL TETRAPEPTIDE-4INACTIVE INGREDIENT87AV1IB2EU6
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG6
POLYQUATERNIUM-10 (400 CPS AT 2%)INACTIVE INGREDIENTHB1401PQFS6
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T6
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49520-10349520-103-11, 49520-103-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
1,3-BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCOLIC ACID0WT12SX38SIACT
POLYQUATERNIUM-10 (400 CPS AT 2%)HB1401PQFSIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ACETYL CARBOXYMETHYL COCOYL GLYCINE3TNX4P92J3IACT
MYRISTOYL TETRAPEPTIDE-487AV1IB2EUIACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
PENTYLENE GLYCOL50C1307PZGIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE / ORAL172 mgExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TPASTILLE / ORALADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TGEL / TOPICAL3 mgExact identifier — unii candidate
13 equally ranked IID candidates
1,3-BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
1,3-BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / ORALADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii candidate
13 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / VAGINAL3 mgExact identifier — unii candidate
13 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f646e74c-7e69-4992-b8d2-0e9661930c828e36c36f-aa9e-4ae2-8dea-53d167e81a7f2013-12-30WarningsExact identifier
spl id: f646e74c-7e69-4992-b8d2-0e9661930c82
spl set id: 8e36c36f-aa9e-4ae2-8dea-53d167e81a7f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.