FDA.reportPublic FDA data

Medicated Body

Manufacturer
Universal Distribution Center LLC
Effective date
2024-06-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:14:12

Label at a glance#

ProductMedicated Body
Active ingredientMENTHOL, UNSPECIFIED FORM, ZINC OXIDE
Label structure8 sections

Indications and uses

for the temporary relief of pain and itching associated with • Backache • Minor Burn • Minor Skin Irritations • Minor Cut • Sunburn • Insect Bites • Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder

Dosage and administration

Adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily Children under 2 years of age: consult a doctor For best results, dry area thoroughly before applying

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.15%

Zinc Oxide 1.0%

Purpose

OTC - PURPOSE SECTION

External analgesic

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with

• Backache • Minor Burn • Minor Skin Irritations

• Minor Cut • Sunburn • Insect Bites

• Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder

WARNING

WARNINGS SECTION

for external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or 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 (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • Children under 2 years of age: consult a doctor
  • For best results, dry area thoroughly before applying

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Zea mays (corn) starch, sodium bicarbonate, tricalcium phosphate, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

SPL UNCLASSIFIED SECTION

WITH ESSENTIAL OILS

Daily Use Leaves Skin Feeling Fresh & Healthy

PURE CORNSTARCH

This product is sold by weight, not by volume. Some settling may occur during handling and shipping.

Distributed By:
Universal Distribution Center
Edison, NJ 08817
www.universaldc.com

Made in India

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5200038-8oz5200038-8oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSN4
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCD4
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSY4
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-038-25Medicated Body283 g in 1 BOTTLEPOWDER2834
52000-038-26Medicated Body226 g in 1 BOTTLEPOWDER2264

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-038MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [UNIVERSAL DISTRIBUTION CENTER LLC]4Current NDC, Legacy NDC, 2 package rows20240627_2a59a847-cc7a-42cf-b49a-92e7254c1629.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-03852000-038-25, 52000-038-26

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
STARCH, CORNO8232NY3SJIACT
SODIUM BICARBONATE8MDF5V39QOIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
GUM TALHAH18F76G097IACT
EUCALYPTOLRV6J6604TKIACT
METHYL SALICYLATELAV5U5022YIACT
SALICYLIC ACIDO414PZ4LPZIACT
THYMOL3J50XA376EIACT
ZINC STEARATEH92E6QA4FVIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
ndc (package): 52000-038-25
ndc (package): 52000-038-26
ndc (product): 52000-038
ndc11 (package): 52000003826
ndc11 (package): 52000003825
spl id: 6af56e16-5a14-4a8b-9491-6891be500637
spl set id: 2a59a847-cc7a-42cf-b49a-92e7254c1629

Reported adverse events (FAERS/openFDA)#

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