FDA.reportPublic FDA data

Aveeno ® Anti-Itch CONCENTRATED LOTION

Manufacturer
Kenvue Brands LLC
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:41:06

Label at a glance#

ProductAveeno Anti-Itch Concentrated
Active ingredientZINC OXIDE, FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For temporary relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak, or poison sumac Dries the oozing and weeping of poison: ivy oak sumac

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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Calamine 3%Skin Protectant
Pramoxine HCl 1%External Analgesic

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of pain and itching associated with:
    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
    • rashes due to poison ivy, poison oak, or poison sumac
  • Dries the oozing and weeping of poison:
    • ivy
    • oak
    • sumac

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last 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, Dimethicone, Camphor, Methylparaben, Sodium Chloride, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernal Flour, Avena Sativa (Oat) Kernel Extract

Questions?

OTC - QUESTIONS SECTION

call toll-free 866-428-3366 or 215-273-8755(collect) www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON &
JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermatologist
Recommended

Aveeno ®

Anti-Itch
CONCENTRATED LOTION
External Analgesic/Skin Protectant

Fast-Acting,
Soothing Itch Relief of:
Poison Ivy/Oak/Sumac,
Insect Bites

Soothes Chicken Pox Rash
and Allergic Itches

Aveeno ®
Dermatologist recommended
for over 65 years

with Triple
Oat Complex

4 fl. oz. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1233698calamine 3 % / pramoxine HCl 1 % Topical LotionPSN6
1233698calamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD6
1233698calamine 3 % / pramoxine hydrochloride 1 % Topical LotionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0475-4Aveeno Anti-Itch Concentrated118 mL in 1 BOTTLELOTION1186

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-047569968-0475-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM CHLORIDE451W47IQ8XIACT
OAT KERNEL OIL3UVP41R77RIACT
OATMEAL8PI54V663YIACT
OATZ6J799EAJKIACT
ZINC OXIDESOI2LOH54ZACTIB
FERRIC OXIDE RED1K09F3G675ACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-05full-release2026-06-01 00:34:17

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
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
ndc (package): 69968-0475-4
ndc (product): 69968-0475
ndc11 (package): 69968047504
spl id: 4231d5a3-ee70-83e1-e063-6294a90a0c9b
spl set id: 07f4d4d0-9cee-46c3-bc71-2024abd31c9e

Reported adverse events (FAERS/openFDA)#

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