FDA.reportPublic FDA data

Banophen

Manufacturer
Major Pharmaceuticals
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:47:16

Label at a glance#

ProductBanophen
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure9 sections

Indications and uses

• temporarily relieves pain and itching associated with: • insect bites • minor burns • sunburn • minor skin irritations • minor cuts • scrapes • rashes due to poison ivy, poison oak and poison sumac • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and administration

• do not use more than directed • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily • children under 2 years of age: ask a doctor

Storage and handling

• store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  1. temporarily relieves pain and itching associated with:
    1. insect bites
    2. minor burns
    3. sunburn
    4. minor skin irritations
    5. minor cuts
    6. scrapes
    7. rashes due to poison ivy, poison oak and poison sumac
  2. dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  1. on large areas of the body
  2. with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  1. on chicken pox
  2. on measles

When using this product

OTC - WHEN USING SECTION

  1. avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  1. condition worsens or does not improve within 7 days
  2. symptoms persist for more than 7 days or clear up and occur again within a few days

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  1. do not use more than directed
  2. adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  3. children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  1. store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

compare to the active ingredients in Extra Strength Benadryl® Itch Stopping Cream

extra strength

banophen™

diphenhydramine HCl 2%

zinc acetate 0.1%

anti-itch cream

topical analgesic skin protectant

net wt 1 oz (28 g)

major-banophen-carton-image.jpg
major-banophen-carton-image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092428Banophen Cream 2 % / 0.1 % Topical CreamPSN5
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN5
1092428diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Banophen Cream]SBD5
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD5
1092428Banophen Cream (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSY5
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5354-31Banophen1 in 1 CARTONCREAM15
0904-5354-31Banophen28 g in 1 TUBECREAM285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5354-31GM - Gram0904-53546a476b0d-917c-4d7b-9b92-2d7e5610846612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
ZINC ACETATEACTIVE INGREDIENTFM5526K07A1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
ZINCACTIVE MOIETYJ41CSQ7QDS1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-53540904-5354-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
DIETHYLENE GLYCOL MONO- AND DIPALMITOSTEARATE94YQ11Y95FIACT
PEG-20 STEARATENBX892EA57IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT

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
BanophenDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMajor Pharmaceuticals9758d886-bd58-4eb2-a827-fa8e7fee2b7c2026-02-13WarningsExact identifier
ndc (package): 0904-5354-31
ndc (product): 0904-5354
ndc11 (package): 00904535431
spl id: 9d9d4074-238a-49d0-a5ef-39414da07434
spl set id: 9758d886-bd58-4eb2-a827-fa8e7fee2b7c

Reported adverse events (FAERS/openFDA)#

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