FDA.reportPublic FDA data

OHEAL SHINGLES PAIN RELIEF Cream

Manufacturer
Dr.luke Healthcare LLC
Effective date
2023-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:34:46

Label at a glance#

ProductOHEAL SHINGLES PAIN RELIEF Cream
Active ingredientMENTHOL
Label structure12 sections

Dosage and administration

Apply to the affected areas 2-3 times daily. Children should use it under the supervision of adults.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

MENTHOL, UNSPECIFIED FORM 3%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

For the treatment of symptomsof shingles, hives, and rashes.

Warnings

WARNINGS SECTION

For external use only.Avoid contact with eyes, flush with water immediately if it getsinto your eyes.Keep out of reach of children.

Do not use

OTC - DO NOT USE SECTION

On broken skin
On eyes area

WHEN USING SECTION

OTC - WHEN USING SECTION

For external use only.Avoid contact with eyes, flush with water immediately if it getsinto your eyes.Keep out of reach of children.

STOP USE section

OTC - STOP USE SECTION

If you are allergic to this product.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to the affected areas 2-3 times daily.
Children should use it under the supervision of adults.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Mineral oil, Glycerin, Cetyl Alcohol, Aloevera Extract,Coconut Oil, Propylene Glycol, Artemisia Extract, K chiaSoparia seeds , Dictamni Cortex, Smilax Glabra Roxb.Solidago decurrens, Phellodendron amurense Ruprecht.Euphorbia Fischeriana Root,Gleditsia Sinensis, StemonaTuberosa,Equally extracted herbalextracts,Sophora flavescensVitamin E.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83176-004-01

83176-004-0183176-004-01

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83176-00483176-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
STEMONA TUBEROSA WHOLE9373ZOT316IACT
ALOEV5VD430YW9IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EUPHORBIA FISCHERIANA ROOTR4DRG4762YIACT
SOPHORA FLAVESCENS WHOLEX8KX602M5LIACT
GLYCERINPDC6A3C0OXIACT
ARTEMISIA PRINCEPS WHOLE2849G48V9JIACT
COCONUT OILQ9L0O73W7LIACT
SOLIDAGO DECURRENS WHOLEY026RJV99TIACT
CETYL ALCOHOL936JST6JCNIACT
BASSIA SCOPARIA FRUIT04W97Z676YIACT
SMILAX LANCEIFOLIA WHOLEWBP9EYZ1XEIACT
PHELLODENDRON AMURENSE WHOLE3OZN5NGR9LIACT
GLEDITSIA SINENSIS WHOLEFS3UB95UTGIACT
DICTAMNUS DASYCARPUS ROOT6153LEN214IACT
MENTHOLL7T10EIP3AACTIB
EQUISETUM ARVENSE BRANCH1L0VKZ185EIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
27648245-e5d0-b1a0-e063-6294a90a4962f684c4e3-f619-b5f1-e053-2a95a90a1e9e2024-11-20WarningsExact identifier
spl set id: f684c4e3-f619-b5f1-e053-2a95a90a1e9e

Reported adverse events (FAERS/openFDA)#

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