FDA.reportPublic FDA data

JACK BLACK PERFORMANCE REMEDY DRAGON ICE

Manufacturer
JACK BLACK LLC
Effective date
2022-01-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:16

Label at a glance#

ProductJACK BLACK PERFORMANCE REMEDY DRAGON ICE
Active ingredientMENTHOL
Label structure10 sections

Dosage and administration

ADULTS AND CHILDREN 2 YEARS OF AGE OR OLDER: APPLY TO AFFECTED AREAS NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER2 YEARS OF AGE CONSULT A DOCTOR. GENTLY MASSAGE INTO ACHY POINTS ON THE BODY. WASH HANDS AFTER USE WITH COOL WATER. PRODUCT WILL GRADUALLY ACTIVATE AND WARM TO PROVIDE LONG-LASTING RELIEF.

Storage and handling

STORE IN COOL, DRY PLACE WITH CAP CLOSED TIGHTLY.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 2.2%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

INDICATIONS

INDICATIONS & USAGE SECTION

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH STRAINS, BRUISES, SPRAINS, SIMPLE BACKACHE, AND ARTHRITIS.

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY.
  • AVOID CONTACT WITH EYES AND MUCOUS MEMBRANES.
  • DO NOT USE ON SENSITIVE AREAS, FACE, OR EYE AREA.
  • IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.
  • DO NOT APPLY TO WOUNDS OR DAMAGED SKIN, OR IRRITATED AREAS.
  • DO NOT BANDAGE TIGHTLY IN THE AREA WHERE PRODUCT IS APPLIED.
  • DO NOT USE A HEATING PAD IN AREA WHERE PRODUCT IS APPLIED.

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 RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

ADULTS AND CHILDREN 2 YEARS OF AGE OR OLDER: APPLY TO AFFECTED AREAS NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER2 YEARS OF AGE CONSULT A DOCTOR. GENTLY MASSAGE INTO ACHY POINTS ON THE BODY. WASH HANDS AFTER USE WITH COOL WATER. PRODUCT WILL GRADUALLY ACTIVATE AND WARM TO PROVIDE LONG-LASTING RELIEF.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, PROPANEDIOL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, DIMETHYL SULFONE, PEG-8 DIMETHICONE, MENTHYL LACTATE, ACTYLATES/C10-30 ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE*, ARNICA MONTANA FLOWER EXTRACT, BETA-GLUCAN, BISABOLOL, BOSWELLIA SERRATA EXTRACT, CARBOMER, CHLORPHENESIN, CINNAMOMUM ZEYLANICUM BARK OIL, CITRUS LIMON (LEMON) PEEL OIL, CROTON LECHLERI RESIN EXTRACT, DISODIUM EDTA, EPILOBUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, EUCALYPTUS GLOBULUS LEAF OIL, GLYCERIN, GLYCINE SOJA (SOYBEAN) SEED EXTRACT*, HYDRASTIS CANADENSIS (GOLDENSEAL) ROOT EXTRACT, LAVENDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT*, LAVENDULA ANGUSTIFOLIA (LAVENDER) OIL, LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, MENTHA PIPERITA (PEPPERMINT) OIL, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ORIGANUM VULGARE LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SODIUM HYDROXIDE, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TOCOPHEROL, THYMOL

*CERTIFIED ORGANIC

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE IN COOL, DRY PLACE WITH CAP CLOSED TIGHTLY.

QUESTIONS?

OTC - QUESTIONS SECTION

1-877-766-3388

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_JB_Dragon Ice01b LBL_JB_Dragon Ice

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2178768menthol 2.2 % Topical CreamPSN3
2178768menthol 22 MG/ML Topical CreamSCD3
2178768menthol 2.2 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66738-101-112025-01-30C16284748780-12cef2736-b660-d83d-e063-dadaa90ab31fJACK BLACK - PERFORMANCE REMEDY DRAGON ICE (66738-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66738-101-11JACK BLACK PERFORMANCE REMEDY DRAGON ICE113 g in 1 TUBECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66738-101JACK BLACK PERFORMANCE REMEDY DRAGON ICE (MENTHOL) CREAM [JACK BLACK LLC]3Legacy NDC, 1 package rows20220104_2db748ee-519f-42d5-aac1-d2737d57fc93.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66738-10166738-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANAO80TY208ZWIACT
CURDLAN6930DL209RIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CHLORPHENESINI670DAL4SZIACT
CINNAMON BARK OILXE54U569ECIACT
LEMON OILI9GRO824LLIACT
CROTON LECHLERI RESINGGG6W25C63IACT
EDETATE DISODIUM7FLD91C86KIACT
EPILOBIUM ANGUSTIFOLIUM WHOLEC278QS9YBTIACT
EUCALYPTUS OIL2R04ONI662IACT
SOYBEANL7HT8F1ZODIACT
GOLDENSEALZW3Z11D0JVIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
LONICERA JAPONICA TOP60Q6UP226VIACT
PEPPERMINT OILAV092KU4JHIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
OREGANO LEAF OIL7D0CGR40U1IACT
ROSEMARY OIL8LGU7VM393IACT
SODIUM HYDROXIDE55X04QC32IIACT
GINGERC5529G5JPQIACT
TOCOPHEROLR0ZB2556P8IACT
THYMOL3J50XA376EIACT
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
d4b682c6-7465-3990-e053-2995a90aeb3f2db748ee-519f-42d5-aac1-d2737d57fc932022-01-03WarningsExact identifier
spl id: d4b682c6-7465-3990-e053-2995a90aeb3f
spl set id: 2db748ee-519f-42d5-aac1-d2737d57fc93

Reported adverse events (FAERS/openFDA)#

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