FDA.reportPublic FDA data

Medicated Body

Manufacturer
New Pride Corp | Jell Pharmaceuticals pvt ltd | Jell Pharmaceuticals Pvt Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:03

Label at a glance#

ProductMedicated Body Powder
Active ingredientMENTHOL
Label structure10 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 irritations dries the oozing of poison ivy, oak and sumac.

Dosage and administration

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#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.15 %

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 irritations
  • dries the oozing of poison ivy, oak and sumac.

Warnings

WARNINGS SECTION

For external use only

When usin this product

OTC - WHEN USING SECTION

Avoid contact with eyes. Not for genital area.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • Redness, irritation, swelling or pain persist 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

  • 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 seyl gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalciun phosphate, zea mays (corn stach), zinc oxide, zinc stearate

Equate Medicated Body Powder Original

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1431703menthol 0.15 % Topical PowderPSN2
1431703menthol 0.0015 MG/MG Topical PowderSCD2
1431703menthol 0.15 % Topical PowderSY2
1431703menthol 1.5 MG per GM Topical PowderSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58037-001-01Medicated BodyPowder283 g in 1 BOTTLEPOWDER2832

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58037-001MEDICATED BODY POWDER (MENTHOL) POWDER [NEW PRIDE CORP]2Current NDC, Legacy NDC, 1 package rows20241222_f0f0e332-cb93-42a7-e053-2995a90ac4ae.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
58037-00158037-001-01

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
SODIUM BICARBONATE8MDF5V39QOIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
ACACIA5C5403N26OIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHYL SALICYLATE, (+/-)-43XOA705ZDIACT
SALICYLIC ACIDO414PZ4LPZIACT
THYMOL3J50XA376EIACT
ZINC STEARATEH92E6QA4FVIACT
ZINC OXIDESOI2LOH54ZIACT
ZEA MAYS WHOLE1G5HNE09V8IACT
MENTHOLL7T10EIP3AACTIB

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 Body PowderMENTHOLNew Pride Corpf0f0e332-cb93-42a7-e053-2995a90ac4ae2024-12-19WarningsExact identifier
ndc (package): 58037-001-01
ndc (product): 58037-001
ndc11 (package): 58037000101
spl id: 299ae5b5-bef2-3de8-e063-6394a90acf91
spl set id: f0f0e332-cb93-42a7-e053-2995a90ac4ae

Reported adverse events (FAERS/openFDA)#

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