JACK BLACK PERFORMANCE REMEDY DRAGON ICE- menthol cream 
JACK BLACK LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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JACK BLACK - PERFORMANCE REMEDY DRAGON ICE (66738-101)

ACTIVE INGREDIENT

MENTHOL 2.2%

PURPOSE

TOPICAL ANALGESIC

INDICATIONS

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

WARNINGS

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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

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

STORE IN COOL, DRY PLACE WITH CAP CLOSED TIGHTLY.

QUESTIONS?

1-877-766-3388

01b LBL_JB_Dragon Ice

JACK BLACK PERFORMANCE REMEDY DRAGON ICE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66738-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA (UNII: O80TY208ZW)  
CURDLAN (UNII: 6930DL209R)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
LEMON OIL (UNII: I9GRO824LL)  
CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SOYBEAN (UNII: L7HT8F1ZOD)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA TOP (UNII: 60Q6UP226V)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GINGER (UNII: C5529G5JPQ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
THYMOL (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66738-101-11113 g in 1 TUBE; Type 0: Not a Combination Product07/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/13/2019
Labeler - JACK BLACK LLC (847024036)

Revised: 1/2022
Document Id: d4b682c6-7465-3990-e053-2995a90aeb3f
Set id: 2db748ee-519f-42d5-aac1-d2737d57fc93
Version: 3
Effective Time: 20220103
 
JACK BLACK LLC