FDA.reportPublic FDA data

myHELPER

Manufacturer
mybody
Effective date
2012-05-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:31:39

Label at a glance#

ProductmyHELPER
Active ingredientBENZOYL PEROXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

OTC - PURPOSE SECTION

PURPOSE

ACNE TREATMENT

INDICATIONS & USAGE SECTION

USE FOR 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 BENZOYL PEROXIDE.

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 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 1-3 TIMES DAILY ONTO CLEAN SKIN. TWIST BASE OF PEN UNTIL PRODUCT APPEARS ON BRUSH. GENTLY APPLY TO PROBLEM AREA. DAILY USE OF SUNSCREEN IS RECOMMENDED.
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE EVERY OTHER DAY.

OTHER SAFETY INFORMATION

OTHER INFORMATION

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

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: WATER,  POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, ACETYL CARBOXYMETHYL COCOYL GLYCINE, PHENOXYETHANOL, CAPRYLYL GLYCOL, DECYLENE GLYCOL, CARBOMER.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MYBODY

MYHELPER

ACNE SPOT TREATMENT
5% BENZOYL PEROXIDE

.07 FL OZ US / 2 ML
myHELPER_UNIT CARTON_2012-04-30
myHELPER_UNIT CARTON_2012-04-30
Twist Tube_Cropped
Twist Tube_Cropped

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308693benzoyl peroxide 5 % Topical CreamPSN3
1292448myHelper 5 % Topical CreamPSN3
1292448benzoyl peroxide 50 MG/ML Topical Cream [Myhelper]SBD3
308693benzoyl peroxide 50 MG/ML Topical CreamSCD3
308693benzoyl peroxide 5 % Topical CreamSY3
1292448myHelper 5 % Topical CreamSY3
1292448Myhelper 50 MG/ML Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49520-102-522019-11-13C16284748780-197449f38-c1ac-f6ea-e053-dbdaa90aa703myHELPER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49520-102-22myHELPER2 mL in 1 APPLICATORCREAM23
49520-102-52myHELPER1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49520-102MYHELPER (BENZOYL PEROXIDE) CREAM [MYBODY]3Legacy NDC, 2 package rows20120504_217f136f-c69c-415a-bd07-1212a6ebf9df.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM3
BENZOIC ACIDACTIVE MOIETY8SKN0B0MIM3
ACETYL CARBOXYMETHYL COCOYL GLYCINEINACTIVE INGREDIENT3TNX4P92J33
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE703
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT92083
DECYLENE GLYCOLINACTIVE INGREDIENTS57M60MI883
LAURETH-7INACTIVE INGREDIENTZ95S6G82013
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWV3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49520-10249520-102-22, 49520-102-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
ACETYL CARBOXYMETHYL COCOYL GLYCINE3TNX4P92J3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DECYLENE GLYCOLS57M60MI88IACT
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT

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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208ENEMA / RECTAL0.24 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208GEL, METERED / TRANSDERMAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208OINTMENT / TOPICAL0.5 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208GEL / TOPICAL30 mgExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208SUSPENSION/ DROPS / OPHTHALMIC0.4 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CREAM / TOPICAL600 mgExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208SUSPENSION / OPHTHALMIC0.45 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CAPSULE / ORAL32 mgExact identifier — unii candidate
14 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208SUSPENSION / ORAL288 mgExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208LOTION / TOPICAL0.5 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208SOLUTION / TOPICAL10 mgExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208TABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
14 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208EMULSION / TOPICAL3405 mgExact identifier — unii candidate
14 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208TABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
14 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 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
e3393b63-1dbc-4c50-b114-da74582319f5217f136f-c69c-415a-bd07-1212a6ebf9df2012-05-03WarningsExact identifier
spl id: e3393b63-1dbc-4c50-b114-da74582319f5
spl set id: 217f136f-c69c-415a-bd07-1212a6ebf9df

Reported adverse events (FAERS/openFDA)#

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