FDA.reportPublic FDA data

Aveeno Calamine & Pramoxine HCl Anti-Itch Cream

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2019-01-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:34:51

Label at a glance#

ProductAveeno Calamine and Pramoxine Hydrochloride Anti Itch
Active ingredientFerric Oxide Red, Zinc Oxide, Pramoxine Hydrochloride
Label structure10 sections

Indications and uses

For temporary relief of pain and itching associated with minor burns, sunburns, 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: consult 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, sunburns, 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

OTC - WHEN USING SECTION

When using this product Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly

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 immediately.

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: consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

  • STORE AT ROOM TEMPERATURE

Inactive ingredients

INACTIVE INGREDIENT SECTION

avena sativa (oat) kernel extract, avena sativa (oat) kernel flour, avena sativa (oat) kernel oil, camphor, cetyl alcohol, dimethicone, distearyldimonium chloride, glycerin, isopropyl palmitate, methylparaben, petrolatum, sodium chloride, water

Questions?

OTC - QUESTIONS SECTION

1-866-428-3366 or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
Johnson & Johnson
CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 28g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermatologist Recommended
Aveeno®
ACTIVE NATURALS®
Calamine & Pramoxine HCl
ANTI-ITCH CREAM
External Analgesic/Skin Protectant
Steroid Free

Effectively relieves Itch from:
Poison Ivy/Oak/Sumac and Insect Bites
Soothes:
Chicken Pox Rash and Allergic Itch

New
Itch Relieving
Formula

Fast-Acting, Soothing Itch Relief
Dries out weepy rashes

NET WT 1 OZ (28g)
With Triple Oat Complex

Principal Display Panel - 28g Tube Carton
Principal Display Panel - 28g Tube Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Ferric Oxide RedACTIVE INGREDIENT1K09F3G6751
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L51
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Ferric Oxide RedACTIVE MOIETY1K09F3G6751
PramoxineACTIVE MOIETY068X84E0561
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Distearyldimonium ChlorideINACTIVE INGREDIENTOM9573ZX3X1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Isopropyl PalmitateINACTIVE INGREDIENT8CRQ2TH63M1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
OatINACTIVE INGREDIENTZ6J799EAJK1
Oat Kernel OilINACTIVE INGREDIENT3UVP41R77R1
OatmealINACTIVE INGREDIENT8PI54V663Y1
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
WaterINACTIVE INGREDIENT059QF0KO0R1

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
58232-991158232-9911-1, 58232-9911-2

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
Ferric Oxide Red1K09F3G675ACTIB
Zinc OxideSOI2LOH54ZACTIB
Pramoxine Hydrochloride88AYB867L5ACTIB
OatZ6J799EAJKIACT
Oatmeal8PI54V663YIACT
Oat Kernel Oil3UVP41R77RIACT
Cetyl Alcohol936JST6JCNIACT
Dimethicone92RU3N3Y1OIACT
Distearyldimonium ChlorideOM9573ZX3XIACT
GlycerinPDC6A3C0OXIACT
Isopropyl Palmitate8CRQ2TH63MIACT
MethylparabenA2I8C7HI9TIACT
Petrolatum4T6H12BN9UIACT
Sodium Chloride451W47IQ8XIACT
Water059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 334 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER / TOPICALNAExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
Isopropyl PalmitateISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOAP / TOPICAL1.26 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
134 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYSTEM / TOPICAL3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii candidate
134 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XJELLY / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / TOPICAL0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVASCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates

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
597a296f-9eb1-466c-a27c-d374e759e8f9a042095e-a139-4c5d-8ffb-39e37da2a93a2019-01-04WarningsExact identifier
spl id: 597a296f-9eb1-466c-a27c-d374e759e8f9
spl set id: a042095e-a139-4c5d-8ffb-39e37da2a93a

Reported adverse events (FAERS/openFDA)#

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