FDA.reportPublic FDA data

Aveeno Calm Plus Restore Itch Relief Balm

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:35

Label at a glance#

ProductAveeno Calm Plus Restore Itch Relief Balm
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

For the temporary relief of itching associated with: minor skin irritations

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Storage and handling

Store at Room Temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl (0.5%)

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with:

  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with the eyes.

OTC - STOP USE 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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

  • Store at Room Temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Panthenol, Dimethicone, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Chlorphenesin, Steareth-20, Aloe Barbadensis Leaf Extract, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

Questions?

OTC - QUESTIONS SECTION

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 113g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Aveeno®

Calm +

Restore

ITCH RELIEF

BALM

Pramoxine HCl external analgesic

Sensitive,

Delicate Skin

Instantly soothes

and helps relieve itch

FRAGRANCE FREE

DERMATOLOGIST RECOMMENDED BRAND

PREBIOTIC OAT, ALOE, PRO-VIT B5

net wt.

4 OZ (113 g)

Aveeno_01Aveeno_01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1150482pramoxine HCl 0.5 % Topical CreamPSN2
1150482pramoxine hydrochloride 5 MG/ML Topical CreamSCD2
1150482pramoxine hydrochloride 0.5 % Topical CreamSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0796-4Aveeno Calm Plus Restore Itch Relief Balm113 g in 1 TUBECREAM1132
69968-0796-4Aveeno Calm Plus Restore Itch Relief Balm1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0796AVEENO CALM PLUS RESTORE ITCH RELIEF BALM (PRAMOXINE HYDROCHLORIDE) CREAM [KENVUE BRANDS LLC]22 package rows20241107_f17e2409-e8d7-37e0-e053-2a95a90a6026.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-079669968-0796-4

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
CETYL ALCOHOL936JST6JCNIACT
BENZYL ALCOHOLLKG8494WBHIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
PANTHENOLWV9CM0O67ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
STEARETH-20L0Q8IK9E08IACT
CHLORPHENESINI670DAL4SZIACT
DIMETHICONE92RU3N3Y1OIACT
OATMEAL8PI54V663YIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OATZ6J799EAJKIACT

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
585edf43-631e-9fa2-e063-6394a90a700cf17e2409-e8d7-37e0-e053-2a95a90a60262026-08-06WarningsExact identifier
spl set id: f17e2409-e8d7-37e0-e053-2a95a90a6026

Reported adverse events (FAERS/openFDA)#

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