FDA.reportPublic FDA data

Debbie's Down & Dirty Deep Tissue Joint and Muscle Cream

Manufacturer
DD&D Manufacturing Co., Ltd
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:06

Label at a glance#

ProductDebbies Down and Dirty Deep Tissue Joint and Muscle
Active ingredientMENTHOL
Label structure6 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple back ache • arthritis • sprains • strains • and bruises

Dosage and administration

Use only as directed Adults and children 12 years of age and older: apply generously to affected area. Massage into painful area until thoroughly absorbed into skin. Children under 12 years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple back ache • arthritis • sprains • strains • and bruises

Warnings

WARNINGS SECTION

For external use only

Do not apply

OTC - DO NOT USE SECTION

to wounds or damaged skin.

Ask a physician before use if

OTC - ASK DOCTOR SECTION

you have redness over the affected area.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.
  • do not bandage.

Stop use and ask a physician if

OTC - STOP USE SECTION

  • condition worsens  or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs.

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

Use only as directed Adults and children 12 years of age and older: apply generously to affected area. Massage into painful area until thoroughly absorbed into skin. Children under 12 years of age: consult a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Carbomer, Cetyl lcohol, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Salic Nigra (Willow Bark) Extract, Triethanolamine, Xanthan Gum.

Package labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253020menthol 10 % Topical CreamPSN2
253020menthol 100 MG/ML Topical CreamSCD2
253020menthol 10 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71523-833-01Debbies Down and Dirty Deep Tissue Joint and Muscle1 in 1 BOXCREAM12
71523-833-01Debbies Down and Dirty Deep Tissue Joint and Muscle118 mL in 1 BOTTLECREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71523-833DEBBIES DOWN AND DIRTY DEEP TISSUE JOINT AND MUSCLE (MENTHOL) CREAM [DD&D MANUFACTURING CO., LTD]2Current NDC, Legacy NDC, 2 package rows20231112_531fe834-53e3-305f-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71523-83371523-833-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
METHYL SALICYLATELAV5U5022YIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WILLOW BARKS883J9JDYXIACT
TROLAMINE9O3K93S3TKIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
BROMELAINSU182GP2CF3IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
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
Debbies Down and Dirty Deep Tissue Joint and MuscleMENTHOLDD&D Manufacturing Co., Ltd531fe834-53e3-305f-e054-00144ff88e882023-11-11WarningsExact identifier
ndc (package): 71523-833-01
ndc (product): 71523-833
ndc11 (package): 71523083301
spl id: 09db6ba6-5806-44a5-e063-6294a90a072f
spl set id: 531fe834-53e3-305f-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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