Jack Black Performance Remedy Dragon Ice
FDA Label NDC 66738-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jack Black Llc for the product Jack Black Performance Remedy Dragon Ice (NDC 66738-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, indications, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - 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

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