FDA.reportPublic FDA data

Dioscorea batata

Manufacturer
Uriel Pharmacy Inc.
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:15

Label at a glance#

ProductDioscorea batata
Active ingredientMYRRH, FRANKINCENSE, GOLD, CHINESE YAM
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Apply to skin as needed. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Myrrha (Myrrh resin) 9X, Olibanum (Rubber resin from wood of incense tree) 9X, Aurum (Metallic gold) 12X, Dioscorea batata (Chinese yam) 16X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Cetyl alcohol, Distilled water, Frankincense oil, Grapefruit seed extract, Isopropyl myristate, Lavender oil, Myrrh oil, Polyoxyl 40 stearate, Rose oil, Sorbic acid, Stearic acid,Stearyl alcohol, Tea tree oil, Xanthan gum

"prepared using rhythmical processes"

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: FOR EXTERNAL USE ONLY.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
shopuriel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dioscorea batata CreamDioscorea batata Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-4178-5Dioscorea batata60 g in 1 TUBECREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-4178DIOSCOREA BATATA CREAM [URIEL PHARMACY INC.]21 package rows20231229_0bb0fd71-2616-37c5-e063-6294a90aed0d.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
48951-417848951-4178-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAVENDER OILZBP1YXW0H8IACT
CETYL ALCOHOL936JST6JCNIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
STEARYL ALCOHOL2KR89I4H1YIACT
XANTHAN GUMTTV12P4NEEIACT
SORBIC ACIDX045WJ989BIACT
FRANKINCENSE OIL67ZYA5T02KIACT
MYRRH OILH74221J5J4IACT
ROSE OILWUB68Y35M7IACT
CITRUS PARADISI SEED12F08874Y7IACT
MYRRHJC71GJ1F3LACTIB
FRANKINCENSER9XLF1R1WMACTIB
GOLD79Y1949PYOACTIB
CHINESE YAM29CIF30B1ZACTIB

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
0d98c946-5ebe-3043-e063-6294a90a9a280bb0fd71-2616-37c5-e063-6294a90aed0d2023-12-28WarningsExact identifier
spl id: 0d98c946-5ebe-3043-e063-6294a90a9a28
spl set id: 0bb0fd71-2616-37c5-e063-6294a90aed0d

Reported adverse events (FAERS/openFDA)#

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