FDA.reportPublic FDA data

Neova

Manufacturer
PhotoMedex, Inc.
Effective date
2011-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:30:27

Label at a glance#

ProductNeova Breakout Control
Active ingredientSalicylic Acid
Label structure10 sections

Indications and uses

• For the treatment of acne. • Helps prevent new acne pimples, blackheads and whiteheads.

Dosage and administration

• Snap the tip at the color ring. • Allow formula to flow down to the opposite tip. • Apply formula with the saturated tip to affected area.

Storage and handling

Avoid storing at excessive heat.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

• For the treatment of acne. • Helps prevent new acne pimples,
blackheads and whiteheads.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, flush
thoroughly with water. Using other topical acne medications at the same time
or immediately following use of this product may increase dryness or
irritation of the skin. If this occurs, only one medication should be used unless
directed by a doctor. Do not insert in ear canal.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, contact a Poison Control
Center immediately or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Snap the tip at the color ring. • Allow formula to flow down
to the opposite tip. • Apply formula with the saturated tip to affected area.

Other Information

STORAGE AND HANDLING SECTION

Avoid storing at excessive heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Hamamelis Virginiana (Witch Hazel)
Water, Aloe Barbadensis Leaf Extract, Isoceteth-20, Methyl Gluceth-20, PEG-6,
Propylene Glycol, Sodium Hydroxide, Sodium PCA, Sorbitol, Tetrasodium EDTA,
Water (Aqua).

Image of Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BreakOutControlBoxLabel112611.jpgImage of Box/LabelImage of Box/Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797892salicylic acid 2 % Medicated PadPSN2
797892salicylic acid 20 MG/ML Medicated PadSCD2
797892salicylic acid 2 % Medicated PadSY2
797892salicylic acid 2 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62362-119-362019-11-13C16284748780-197449f38-bd50-f6ea-e053-dbdaa90aa703Neova Breakout Control - Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62362-119-05Neova Breakout Control5 mL in 1 APPLICATORSWAB52
62362-119-36Neova Breakout Control36 in 1 BOXSWAB362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62362-119NEOVA BREAKOUT CONTROL (SALICYLIC ACID) SWAB [PHOTOMEDEX, INC.]2Legacy NDC, 2 package rows20111229_5777250f-9496-47f8-a2f0-294c7c928a47.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ2
Salicylic AcidACTIVE MOIETYO414PZ4LPZ2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62362-11962362-119-05, 62362-119-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Allantoin344S277G0ZIACT
Hamamelis Virginiana Leaf Water8FP93ED6H2IACT
Aloe Vera LeafZY81Z83H0XIACT
Isoceteth-20O020065R7ZIACT
Methyl Gluceth-20J3QD0LD11PIACT
Polyethylene Glycol 3005655G9Y8AQIACT
Propylene Glycol6DC9Q167V3IACT
Sodium Hydroxide55X04QC32IIACT
Sodium Pyrrolidone Carboxylate469OTG57A2IACT
Sorbitol506T60A25RIACT
Edetate SodiumMP1J8420LUIACT
Water059QF0KO0RIACT

Source Document#

Source XML

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
e42c5d41-b58a-41c1-834b-ea55a83bd6855777250f-9496-47f8-a2f0-294c7c928a472011-12-28WarningsExact identifier
spl id: e42c5d41-b58a-41c1-834b-ea55a83bd685
spl set id: 5777250f-9496-47f8-a2f0-294c7c928a47

Reported adverse events (FAERS/openFDA)#

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