FDA.reportPublic FDA data

Armand Medicated Anti itch Cream

Manufacturer
Weeks and Leo, Inc. | Weeks & Leo, Inc.
Effective date
2024-12-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:41:28

Label at a glance#

ProductFreds Medicated anti itch
Active ingredientPRAMOXINE HYDROCHLORIDE, MENTHOL
Label structure9 sections

Indications and uses

for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac

Dosage and administration

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: consult a doctor

Storage and handling

store at controlled room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Pramoxine hydrochloride 1%

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac

Purpose

OTC - PURPOSE SECTION

Topical anagesic

Warnings

WARNINGS SECTION

External use only

When using product do not get into eyes

Stop use and ask a doctor if ▪ conditions get worse ▪ symptoms get worse ▪ symptoms last for more than 7 days or clear up and occur again within a few days

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

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other Information

STORAGE AND HANDLING SECTION

store at controlled room temperature

Directions

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: consult a doctor

DOSAGE & ADMINISTRATION SECTION

Adults and Children 2 years and older: Apply to affected are not more than 3 to 4 times daily.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN8
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD8
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
11383-265-012022-01-21C16284748780-1ba0f9c33-5874-a910-e053-dadaa90a0b85Armand Medicated Anti itch Cream
11383-265-012021-01-29C16284748780-1ba0f9c33-5874-a910-e053-dadaa90a0b85Armand Medicated Anti itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11383-265-01Freds Medicated anti itch1 in 1 CARTONCREAM18
11383-265-01Freds Medicated anti itch28 g in 1 TUBECREAM288

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11383-265FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [WEEKS AND LEO, INC.]8Legacy NDC, 2 package rows20241210_8697e625-4c77-3ad6-e053-2991aa0ae50e.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11383-26511383-265-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARETH-2153J3F32P58IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
SODIUM ACRYLATE7C98FKB43HIACT
MINERAL OILT5L8T28FGPIACT
EDETATE DISODIUM7FLD91C86KIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYL SALICYLATELAV5U5022YIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PPG-1 TRIDECETH-61K7417JX6QIACT
EUCALYPTUS OIL2R04ONI662IACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
MENTHOLL7T10EIP3AACTIB

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
28cca776-05ac-bcc9-e063-6294a90aac958697e625-4c77-3ad6-e053-2991aa0ae50e2024-12-08WarningsExact identifier
spl id: 28cca776-05ac-bcc9-e063-6294a90aac95
spl set id: 8697e625-4c77-3ad6-e053-2991aa0ae50e

Reported adverse events (FAERS/openFDA)#

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