FDA.reportPublic FDA data

Au Kah Chuen Fugical

Manufacturer
Zhejiang Dingtai Pharmaceutical Co., Ltd
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:43:08

Label at a glance#

ProductAu Kah Chuen Fugical
Active ingredientZINC OXIDE, FERRIC OXIDE RED, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Storage and handling

Other information keep tightly sealed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Calamine 10%
Diphenhydramine hydrochloride 2%

OTC - PURPOSE SECTION

Purpose
Skin protectant
External analgesic

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of pain, itching, and rushes due to:
poison ivy
poison oak
poison sumac

Dries the oozing and weeping of:
poison ivy
poison oak
poison sumac

WARNINGS SECTION

Warnings
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

conditions worsens
condition does not improve within 7 days
symptoms 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.

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and children 2 years of age or older: Apply liberally to affected area not more than 3 to 4 times daily.
Children under 2 years: Do not use, consult a doctor

STORAGE AND HANDLING SECTION

Other information
keep tightly sealed

INACTIVE INGREDIENT SECTION

Inactive ingredientsAlcohol, camphor, ceteth-20, cetostearyl alcohol, light mineral oil, menthol, methylparaben, petrolatum, propylparaben, silicon dioxide and water.

OTC - QUESTIONS SECTION

Questions or comments?(888) 221-3496 M-F 9am-5pm
you may also report serious side effects to this phone number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Au Kah Chuen Fugical Cream
Calamine 10%
Diphenhydramine hydrochloride 2%
External Analgesic and Poison Ivy, Oak, and Sumac Drying Cream
Net Wt. 0.5 oz (15 g)
NDC 69070-306-01
Unitbox-01.jpgUnitbox-01.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2727332calamine 10 % / diphenhydrAMINE hydrochloride 2 % Topical CreamPSN3
2727332calamine 100 MG/ML / diphenhydramine hydrochloride 20 MG/ML Topical CreamSCD3
2727332calamine 10 % / diphenhydramine hydrochloride 2 % Topical CreamSY3

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
69070-306-01Au Kah Chuen Fugical1 in 1 BOXCREAM13
69070-306-01Au Kah Chuen Fugical15 g in 1 TUBECREAM153

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
69070-30669070-306-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LIGHT MINERAL OILN6K5787QVPIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM
FERRIC OXIDE RED1K09F3G675ACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-25full-release2026-06-01 00:39:17

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
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
ndc (package): 69070-306-01
ndc (product): 69070-306
ndc11 (package): 69070030601
spl id: 4345b4b7-3e93-9d68-e063-6294a90a7d77
spl set id: 5b4add17-6c3d-4093-826a-2edb41c1d1db

Reported adverse events (FAERS/openFDA)#

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