Proactiv Solution Anti-Itch Scalp

Manufacturer
Guthy-Renker LLC.
Effective date
2012-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:49:42

Label at a glance#

ProductProactiv Solution Anti-Itch Scalp
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

temporarily relieves scalp itching associated with minor skin irrations, inflammation and rashes due to: seborrheic dermatitis psoriasis eczema soaps cosmetics insect bites poison ivy, oak, sumac other uses of this product should only be used under the advice and supervision of a doctor.

Dosage and administration

adults and children 2 years of age and older – apply to affected scalp area only, no more than 3-4 times daily. part hair and lightly spray directly onto the affected area. be sure the solution reaches the scalp and the entire area is covered. can gently spread over the area with fingers. wash hands.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 0.28%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves scalp itching associated with minor skin irrations, inflammation and rashes due to:
    • seborrheic dermatitis
    • psoriasis
    • eczema
    • soaps
    • cosmetics
    • insect bites
    • poison ivy, oak, sumac
  • other uses of this product should only be used under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

For external use only

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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not exceed recommended daily dosage unless directed by a doctor
  • do not cover treated skin
  • consult a doctor before use if you are using any other hydrocortisone products
  • keep away from the eyes
  • if contact with eyes occurs, flush liberally with water.

OTC - STOP USE SECTION

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older – apply to affected scalp area only, no more than 3-4 times daily.
  • part hair and lightly spray directly onto the affected area.
  • be sure the solution reaches the scalp and the entire area is covered.
  • can gently spread over the area with fingers.
  • wash hands.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, alcohol denat., butylene glycol, vitis vinifera (grape) seed extract, camellia oleifera leaf extract, salix alba (willow) bark extract, salicylic acid, leptospermone, isoleptospermone, flavesone, allantoin, methylpropanediol, polysorbate 80, PEG-40 hydrogenated castor oil, fragrance.

SPL UNCLASSIFIED SECTION

Dist by Guthy-Renker® ∙ PO Box 14383 ∙ Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rodan & Fields

proactiv®
SOLUTION

ANTI-ITCH
SCALP SPRAY

ANTIDANDRUFF THERAPY®

with hydrocortisone

0.5 FL. OZ. 15 mL

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 15 ml Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11410-602-052020-01-16C16284748780-197449f38-cd79-f6ea-e053-dbdaa90aa703Proactiv Solution Anti-Itch Scalp Spray
11410-602-052019-11-13C16284748780-197449f38-cd79-f6ea-e053-dbdaa90aa703Proactiv Solution Anti-Itch Scalp Spray

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJ1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C601
METHYLPROPANEDIOLINACTIVE INGREDIENTN8F53B3R4R1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8F1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H71
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
11410-60211410-602-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 2 · 90 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / RECTAL72.15 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAVENOUS1170 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS4739 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER / ORAL66 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS53 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SOFT TISSUE4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HDROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / ORAL907 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FSOLUTION / OPHTHALMIC3 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPASTE / ORAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / TOPICAL0.98 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FTABLET / ORAL120 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / AURICULAR (OTIC)13 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER, FOR SUSPENSION / ORAL396 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVITREAL0.02 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSYSTEM / TOPICAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRASYNOVIAL0.2 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FSOLUTION/ DROPS / OPHTHALMIC0.53 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FCAPSULE, COATED / ORAL101.25 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HENEMA / RECTAL0.01 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / RECTAL315 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HEMULSION / OPHTHALMIC26 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / VAGINAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY / NASAL0.01 mgExact identifier — unii candidate
78 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGRANULE, FOR SUSPENSION / ORAL240 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FTABLET, EXTENDED RELEASE / ORAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FSOLUTION / DENTAL1 %w/wExact identifier — unii candidate
9 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
17cf5607-dd7f-4375-a698-b145cfcac43bf23613e5-a437-4aa4-bbf7-290131463d242012-02-02WarningsExact identifier
spl id: 17cf5607-dd7f-4375-a698-b145cfcac43b
spl set id: f23613e5-a437-4aa4-bbf7-290131463d24

Reported adverse events (FAERS/openFDA)#

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