FDA.reportPublic FDA data

MAXIMUM STRENGTH MEDICATED ANTI-ITCH

Manufacturer
Rite Aid | Product Quest Mfg
Effective date
2017-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:37

Label at a glance#

ProductMAXIMUM STRENGTH MEDICATED ANTI-ITCH Rite Aid
Active ingredientMenthol, Pramoxine Hydrochloride
Label structure7 sections

Dosage and administration

Adults and children 2 years of age and older: ​ apply to the affected area no more than 4 times daily Children under 2 years of age : consult a doctor

Label contents#

Full prescribing information#

Active ingredients                                     Purpose

OTC - ACTIVE INGREDIENT SECTION

Menthol – 1.00%                                      External Analgesic   
Pramoxine Hydrochloride – 1.00%            External Analgesic

INDICATIONS & USAGE SECTION

​Uses​ For temporarily relief of pain and itching associated with:• sunburn • minor burns • scrapes • insect bites • minor skin irritation • minor cuts • rashes due to poison ivy, oak & sumac

WarningsFor external use only

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product • Avoid contact with eyes • not for prolonged use

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens
• symptoms persisit more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older:​ apply to the affected area no more than 4 times daily
  • Children under 2 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Leaf Juice, Sodium Acrylates Copolymer, Steareth-21, Mineral Oil,
Steareth-2, Tocopheryl Acetate, Thymol, Eucalyptol, Methyl Salicylate, PPG-1 Trideceth-6, Diazolidinyl Urea, Disodium EDTA, Triethanolamine,
Iodopropynyl Butylcarbamate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN1
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD1
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-7777-12020-01-31C16284748780-19d75b9d0-8d22-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7777-1MAXIMUM STRENGTH MEDICATED ANTI-ITCHRite Aid28 g in 1 TUBECREAM281
11822-7777-1MAXIMUM STRENGTH MEDICATED ANTI-ITCHRite Aid1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7777MAXIMUM STRENGTH MEDICATED ANTI-ITCH RITE AID (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [RITE AID]1Legacy NDC, 2 package rows20171004_4488c378-13b5-456f-b534-cce58168412b.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-777711822-7777-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
Pramoxine Hydrochloride88AYB867L5ACTIB
Water059QF0KO0RIACT
Propylene Glycol6DC9Q167V3IACT
Petrolatum4T6H12BN9UIACT
Stearyl Alcohol2KR89I4H1YIACT
ALOE VERA LEAFZY81Z83H0XIACT
Steareth-2153J3F32P58IACT
Mineral OilT5L8T28FGPIACT
Steareth-2V56DFE46J5IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
Thymol3J50XA376EIACT
EucalyptolRV6J6604TKIACT
Methyl SalicylateLAV5U5022YIACT
PPG-1 Trideceth-61K7417JX6QIACT
Diazolidinyl UreaH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
TROLAMINE9O3K93S3TKIACT
Iodopropynyl Butylcarbamate603P14DHEBIACT
ACRYLAMIDE20R035KLCIIACT

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
f879a43d-90f4-48c3-9cf8-946db0b6637e4488c378-13b5-456f-b534-cce58168412b2017-10-03WarningsExact identifier
spl id: f879a43d-90f4-48c3-9cf8-946db0b6637e
spl set id: 4488c378-13b5-456f-b534-cce58168412b

Reported adverse events (FAERS/openFDA)#

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