JACK BLACK PERFORMANCE REMEDY DRAGON ICE- menthol cream

JACK BLACK PERFORMANCE REMEDY DRAGON ICE by

Drug Labeling and Warnings

JACK BLACK PERFORMANCE REMEDY DRAGON ICE by is a Otc medication manufactured, distributed, or labeled by JACK BLACK LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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.

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JACK BLACK PERFORMANCE REMEDY DRAGON ICE 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-101-11	113 g in 1 TUBE; Type 0: Not a Combination Product	07/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/13/2019

Labeler - JACK BLACK LLC (847024036)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(66738-101)