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| Product NDC Code | 66738-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Jack black performance remedy dragon ice |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 2178768 | ||||
| Application Number | part348 | ||||
| Labeler Name | JACK BLACK LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT MENTHOL 2.2%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH STRAINS, BRUISES, SPRAINS, SIMPLE BACKACHE, AND ARTHRITIS.
Purpose
Information about the drug product’s indications for use.PURPOSE TOPICAL ANALGESIC
Spl product data elements
Usually a list of ingredients in a drug product.JACK BLACK PERFORMANCE REMEDY DRAGON ICE MENTHOL WATER PROPANEDIOL CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE DIMETHYL SULFONE PEG-8 DIMETHICONE MENTHYL LACTATE, (-)- CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALOE VERA LEAF ARNICA MONTANA CURDLAN .ALPHA.-BISABOLOL, (+)- BOSWELLIA SERRATA WHOLE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CHLORPHENESIN CINNAMON BARK OIL LEMON OIL CROTON LECHLERI RESIN EDETATE DISODIUM EPILOBIUM ANGUSTIFOLIUM WHOLE EUCALYPTUS OIL SOYBEAN GOLDENSEAL LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER LONICERA CAPRIFOLIUM FLOWER LONICERA JAPONICA TOP PEPPERMINT OIL OLEA EUROPAEA LEAF OREGANO LEAF OIL ROSEMARY OIL SODIUM HYDROXIDE GINGER TOCOPHEROL THYMOL MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.01b LBL_JB_Dragon Ice
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? 1-877-766-3388
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION STORE IN COOL, DRY PLACE WITH CAP CLOSED TIGHTLY.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API