Label: JACK BLACK PERFORMANCE REMEDY DRAGON ICE- menthol cream
- NDC Code(s): 66738-101-11
- Packager: JACK BLACK LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 3, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS
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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
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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.
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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
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JACK BLACK PERFORMANCE REMEDY DRAGON ICE
menthol creamProduct 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)
