FDA.reportPublic FDA data

talc-free medicated body

Manufacturer
Davion, Inc
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:05

Label at a glance#

Producttalc-free medicated body
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporary relief of pain and itch associated with: minor cuts sunburn insect bites scrapes minor burns minor skin irritations

Dosage and administration

Remove seal beneath cap before first use. Do not use if seal is broken or missing. adults and children 2 years and older - apply freely upto 3 or 4 times daily children under 2 years - ask a doctor For best results, dry skin throughly before applying

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.15%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief of pain and itch associated with:

  • minor cuts
  • sunburn
  • insect bites
  • scrapes
  • minor burns
  • minor skin irritations

Warning

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Remove seal beneath cap before first use. Do not use if seal is broken or missing.

  • adults and children 2 years and older - apply freely upto 3 or 4 times daily
  • children under 2 years - ask a doctor

For best results, dry skin throughly before applying

Inactive ingredients

INACTIVE INGREDIENT SECTION

Zea Mays (Corn) Starch, zinc oxide, Tricalcium Phosphate, Sodium Bicarbonate, salicylic acid, zinc stearate, Eucalyptus oil, Peppermint Oil

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42669-209-01

Compare to active ingredient in Gold Bond® Medicated Body Powder*

talc-free medicated body powder

triple relief formulahelps absorb moisture

helps soothe skin and relieves itching

NET WT 10oz (283 g)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1431703menthol 0.15 % Topical PowderPSN4
1431703menthol 0.0015 MG/MG Topical PowderSCD4
1431703menthol 0.15 % Topical PowderSY4
1431703menthol 1.5 MG per GM Topical PowderSY4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42669-209-012024-02-28C16284748780-11030e365-4d5c-111a-e063-dadaa90a10e2talc-free medicated body powder
42669-209-012024-01-30C16284748780-11030e365-4d5c-111a-e063-dadaa90a10e2talc-free medicated body powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42669-209-01talc-free medicated body283 g in 1 BOTTLEPOWDER2834

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42669-20942669-209-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
ZINC OXIDESOI2LOH54ZIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
SODIUM BICARBONATE8MDF5V39QOIACT
SALICYLIC ACIDO414PZ4LPZIACT
EUCALYPTUS OIL2R04ONI662IACT
ZINC STEARATEH92E6QA4FVIACT
PEPPERMINT OILAV092KU4JHIACT
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
talc-free medicated bodyMENTHOLDavion, Inc27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b2025-12-29WarningsExact identifier
ndc (package): 42669-209-01
ndc (product): 42669-209
ndc11 (package): 42669020901
spl id: 60964e7d-58f7-411e-8af2-5d77e50ba659
spl set id: 27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b

Reported adverse events (FAERS/openFDA)#

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