Restoral

Manufacturer
Peer Pharma Ltd.
Effective date
2018-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:54

Label at a glance#

ProductRestoral
Active ingredientSALICYLIC ACID
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Restoral OTCRestoral OTC

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid, 2%

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 - PURPOSE SECTION

Uses
Relieves and helps prevent recurrence of skin itching

  • irritation
  • redness
  • flaking
  • scaling

due to psoriasis and seborrheic dermatitis

INDICATIONS & USAGE SECTION

Directions

  • apply to affected areas one to four times daily or as directed by a doctor
  • massage a liberal amount of the product into skin until thoroughly absorbed

WARNINGS SECTION

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply to affected areas one to four times daily or as directed by a doctor
  • massage a liberal amount of the product into skin until thoroughly absorbed

INACTIVE INGREDIENT SECTION

Inactive ingredients

water, glyceryl stearate, PEG-100 stearate, glycerin, niacinamide, calendula officinalis flower oil, cannabis sativa seed oil, cetyl alcohol, butyrospermum parkii (shea butter), petrolatum, allantoin, steareth-21, tocopheryl acetate (vitamin E), lavandula angustifolia (lavender) oil, xanthan gum, dipotassium glycyrrhizate, aloe barbadensis leaf juice, triethanolamine, bisabolol, disodium EDTA, maris sal (dead sea mineral water).

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN1
317152salicylic acid 20 MG/ML Topical CreamSCD1
317152salicylic acid 2 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69435-1805-12021-01-29C16284748780-1ba0f9c33-2381-a910-e053-dadaa90a0b85Restoral

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1805-1Restoral150 mL in 1 CONTAINERCREAM1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1805RESTORAL (SALICYLIC ACID CREAM) CREAM [PEER PHARMA LTD.]1Legacy NDC, 1 package rows20180614_6e9bb6aa-2b24-84fb-e053-2991aa0ae6ef.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-180569435-1805-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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
6e9bb6cf-28d7-7e2e-e053-2a91aa0ae7fd6e9bb6aa-2b24-84fb-e053-2991aa0ae6ef2018-06-14Exact identifier
spl id: 6e9bb6cf-28d7-7e2e-e053-2a91aa0ae7fd
spl set id: 6e9bb6aa-2b24-84fb-e053-2991aa0ae6ef

Reported adverse events (FAERS/openFDA)#

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