FDA.reportPublic FDA data

RENEWAL

Manufacturer
RITE AID
Effective date
2010-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:13

Label at a glance#

ProductRENEWAL MEDICATED
Active ingredientMENTHOL, DIMETHICONE
Label structure5 sections

Indications and uses

USES: TO HELP MOISTURIZE, RELIEVE AND PROTECT DRY/ITCHY SKIN. RECOMMENDED FOR REPEATED USE. DIRECTIONS: APPLY TO DRY, ITCHY SKIN AS OFTEN AS NEEDED

Dosage and administration

USES: TO HELP MOISTURIZE, RELIEVE AND PROTECT DRY/ITCHY SKIN. RECOMMENDED FOR REPEATED USE. DIRECTIONS: APPLY TO DRY, ITCHY SKIN AS OFTEN AS NEEDED

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

  • MENTHOL 0.5% (TOPICAL ANALGESIC)
  • DIMETHICONE 5.0% (SKIN PROTECTANT)

USES AND DIRECTIONS

OTC - PURPOSE SECTION

  • USES: TO HELP MOISTURIZE, RELIEVE AND PROTECT DRY/ITCHY SKIN. RECOMMENDED FOR REPEATED USE.
  • DIRECTIONS: APPLY TO DRY, ITCHY SKIN AS OFTEN AS NEEDED

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

QUESTIONS/COMMENTS?

OTC - QUESTIONS SECTION

1-866-695-3030

PACKAGE FRONT AND BACK LABELS (14OZ)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • 14OZ FRONT AND BACK LABELS: ra14.jpgFRONT AND BACK LABELSFRONT AND BACK LABELS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053386dimethicone 5 % / menthol 0.5 % Topical LotionPSN1
1053386dimethicone 50 MG/ML / menthol 5 MG/ML Topical LotionSCD1
1053386dimethicone 5 % / menthol 0.5 % Topical LotionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-3351-42020-01-31C16284748780-19d75b9cf-d95b-f424-e053-dadaa90a57ceDRUG FACTS BOX(BACK LABEL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3351-4RENEWALMEDICATED414 mL in 1 BOTTLE, PUMPLOTION4141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3351RENEWAL MEDICATED (MENTHOL - DIMETHICONE) LOTION [RITE AID ]1Legacy NDC, 1 package rows20100715_563544c8-1500-4850-9572-0aa837be22d1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
MENTHOLACTIVE MOIETYL7T10EIP3A1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-335111822-3351-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
DIMETHICONE92RU3N3Y1OACTIB

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
dd309d13-5798-415a-968c-845113bc3d6e563544c8-1500-4850-9572-0aa837be22d12010-07-14WarningsExact identifier
spl id: dd309d13-5798-415a-968c-845113bc3d6e
spl set id: 563544c8-1500-4850-9572-0aa837be22d1

Reported adverse events (FAERS/openFDA)#

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