FDA.reportPublic FDA data

Health Smart Medicated Body

Manufacturer
International Wholesale Inc dba Home Smart Products | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:45:14

Label at a glance#

ProductHealth Smart Medicated Body
Active ingredientMENTHOL, ZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%

OTC - PURPOSE SECTION

Purpose

External Analgesic

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of pains 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 SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this productavoid contact with eyes.

OTC - ASK DOCTOR SECTION

Consult a doctor and discontinue use if

  • condition worsens
  • symptoms do not get better within 1 week or clear up and occurs again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 2 years and over

  • apply to the affected area not more than 3 or 4 times daily.
  • children under 2 years of age: consult a physician.
  • for best results, dry skin thoroughly before use.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSN6
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCD6
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSY6
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSY6

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
52862-030-01Health Smart Medicated Body283 g in 1 BOTTLEPOWDER2836

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-030HEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]6Current NDC, 1 package rows20241222_044870e2-ebac-a095-e063-6294a90a2751.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52862-03052862-030-01

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
TRICALCIUM PHOSPHATEK4C08XP666IACT
SODIUM BICARBONATE8MDF5V39QOIACT
SALICYLIC ACIDO414PZ4LPZIACT
ACACIA5C5403N26OIACT
EUCALYPTUS OIL2R04ONI662IACT
METHYL SALICYLATELAV5U5022YIACT
THYMOL3J50XA376EIACT
ZINC STEARATEH92E6QA4FVIACT
ZEA MAYS SUBSP. MAYS WHOLE1G5HNE09V8IACT
MENTHOLL7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
Health Smart Medicated BodyMENTHOL AND ZINC OXIDEInternational Wholesale Inc dba Home Smart Products044870e2-ebac-a095-e063-6294a90a27512024-12-19WarningsExact identifier
ndc (package): 52862-030-01
ndc (product): 52862-030
ndc11 (package): 52862003001
spl id: 299b0d45-09ec-7739-e063-6394a90a0abe
spl set id: 044870e2-ebac-a095-e063-6294a90a2751

Reported adverse events (FAERS/openFDA)#

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