Label: REZIL - capsaicin lotion

  • NDC Code(s): 76468-121-01, 76468-121-04
  • Packager: Toqara, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/11

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS SECTION

    DRUG FACTS

    CAPSAICIN 0.025%

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  • PURPOSE SECTION

    TOPICAL ANALGESIC

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  • KEEP OUT OF REACH OF CHILDREN SECTION

    KEEP AWAY FROM CHILDREN.

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  • INDICATIONS AND USES SECTION

    USES: FOR TEMPORARY RELIEF OF MINOR ACHES, AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, STRAINS, SPRAINS, AND BRUISES.

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  • WARNINGS SECTION

    WARNINGS: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. IF CONDITION WORSEN, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE A CONSULT A PHYSICIAN. DO NOT APPLY TO WOUNDS OR DAMAGED SKIN. DO NOT BANDAGE TIGHTLY.

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  • DOSAGE AND ADMINISTRATION SECTION

    DIRECTIONS: ADULTS AND CHILDREN OVER 6 YEARS OF AGE - APPLY TO AFFECTED AREA AND RUB GENTLY UNTIL ABSORBED. DO NOT USE MORE THAN 3 OR 4 TIMES DAILY.

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  • INACTIVE INGREDIENTS SECTION

    ISOHEXADECANE, MINERAL OIL AND DIMETHICONE

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  • QUESTIONS OR COMMENTS SECTION

    QUESTIONS OR COMMENTS? 1-800-000-0000 OR GO TO WWW.TOQARA.COM

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  • OTHER INFORMATION SECTION

    OTHER INFORMATION: STORE AT ROOM TEMPERATURE

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  • PACKAGE LABEL SECTION

    REZIL PAIN RELIEF LOTION ROLL-ON

    PENETRATING PAIN RELIEF FOR ARTHRITIS, STRAINS, SPRAINS AND BRUISES

    NET 3 FLUID OZ./88ML  MANUFACTURED FOR TOQARA, INC. LAKEWOOD, CO 80214


    REZIL LABEL











    REZIL PAIN RELIEF LOTION ROLL-ON  PENETRATING PAIN RELIEF FOR ARTHRITIS, STRAINS, SPRAINS AND BRUISES
    HANDY POCKET/PURSE SIZE ROLL-ON  READ BACK OF CARD FOR FULL DETAILS  RETAIN INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS 
    NET 1/4 FLUID OX./7.4 ML.
    MANUFACTURED FOR:TOQARA, INC. LAKEWOOD, CO 80214 USA, 303-205-9032  WWW.REZIL.COM


    REZIL PRODUCT LABEL


    REZIL FRONT LABEL

    REZIL BACK LABEL

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  • INGREDIENTS AND APPEARANCE
    REZIL 
    capsaicin lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76468-121
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (CAPSAICIN) CAPSAICIN 0.025 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOHEXADECANE  
    MINERAL OIL  
    DIMETHICONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76468-121-04 88 mL in 1 BOTTLE, WITH APPLICATOR
    2 NDC:76468-121-01 7.4 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/01/2011
    Labeler - Toqara, Inc. (034921977)
    Registrant - Toqara, Inc. (034921977)
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