FDA.reportPublic FDA data

HealthWise Medicated Extra Body Powder 10 oz

Manufacturer
Veridian Healthcare | Jell Pharmaceuticals
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:43:55

Label at a glance#

ProductHealthWise Medicated Extra Body Powder 10 oz
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

for the temporary relief of the pain and itch associated with: ■ minor cuts ■ scrapes ■ sunburn ■ insect bites ■ prickly heat ■ rashes ■ minor burns ■ minor skin irritation ■ dries the oozing of poison ivy, oak, and sumac.

Dosage and administration

Directions ■ Adults and children 2 years of age and over: apply freely up to 3 or 4 times daily ■ Children under 2 years: consult a physician ■ For best results, dry skin thoroughly before use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.80%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION


for the temporary relief of the pain and itch associated with:
■ minor cuts ■ scrapes ■ sunburn ■ insect bites ■ prickly heat ■ rashes ■ minor burns ■ minor skin irritation ■ dries the oozing of poison ivy, oak, and sumac.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes.

Stop use and consult a doctor if

OTC - STOP USE SECTION

■ Condition worsens ■ Redness, irritation, swelling or pain persists or increases ■ Symptoms do not get better within 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

Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
■ Adults and children 2 years of age and over: apply freely up to 3 or 4 times daily ■ Children under 2 years: consult a physician ■ For best results, dry skin thoroughly before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acacia seyal gum, eucalyptus oil, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalcium phosphate, zea mays (corn) starch, zinc oxide, zinc stearate

Questions or comments

OTC - QUESTIONS SECTION

Call toll-free 1-866-326-1313

HealthWise Medicated Extra Body Powder

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2169968menthol 0.8 % Topical PowderPSN1
2169968menthol 0.008 MG/MG Topical PowderSCD1
2169968menthol 8 MG per GM Topical PowderSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-047-01HealthWise Medicated Extra Body Powder 10 oz283 g in 1 BOTTLEPOWDER2831

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-047HEALTHWISE MEDICATED EXTRA BODY POWDER 10 OZ (MENTHOL) POWDER [VERIDIAN HEALTHCARE]1Current NDC, 1 package rows20241218_296c9a9c-e3db-59fe-e063-6294a90a0b62.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-04771101-047-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC STEARATEH92E6QA4FVIACT
SALICYLIC ACIDO414PZ4LPZIACT
ACACIA5C5403N26OIACT
THYMOL3J50XA376EIACT
SODIUM BICARBONATE8MDF5V39QOIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
ZINC OXIDESOI2LOH54ZIACT
EUCALYPTUS OIL2R04ONI662IACT
STARCH, CORNO8232NY3SJIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YIACT

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
HealthWise Medicated Extra Body Powder 10 ozMENTHOLVeridian Healthcare296c9a9c-e3db-59fe-e063-6294a90a0b622024-12-16WarningsExact identifier
ndc (package): 71101-047-01
ndc (product): 71101-047
ndc11 (package): 71101004701
spl id: 296c9a9c-e3dc-59fe-e063-6294a90a0b62
spl set id: 296c9a9c-e3db-59fe-e063-6294a90a0b62

Reported adverse events (FAERS/openFDA)#

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