DANCERS SELECT (MENTHOL, CAMPHOR) GEL [BLAINE LABS INC.]

DANCERS SELECT (MENTHOL, CAMPHOR) GEL [BLAINE LABS INC.]
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NDC 63347-415-01, 63347-415-02
Set ID ab828418-e66a-4b88-905d-745bbe1cfcf9
Category HUMAN OTC DRUG LABEL
Packager Blaine Labs Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • DRUG FACTSACTIVE INGREDIENT

    MENTHOL 3.5%

    CAMPHOT 0.2%

  • PURPOSE

    TOPICAL ANALGESIC

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • INDICATIONS

    • FOR TEMPORARY RELIEF FROM MINOR ACHES AND PAINS OF SORE MUSCLES AND JOINTS ASSICIATED WITH ARTHRITIS PAIN, BACKACHE, STRAINS AND SPRAINS.
  • WARNINGS

    USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY. DO NOT USE WITH OTHER SPRAYS, OINTMENTS, CREAMS OR LINIMENTS. DO NOT APPLY TO IRRITATED SKIN AND DISCONTINUE USE IF EXCESSIVE SKIN IRRITATION DEVELOPS. DO NOT BANDAGE. DO NOT USE WITH HEATING PADS OR DEVICES. WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES OR MUCUS MEMBRAMES.

    ASK YOUR PHYSICIAN BEFORE USING ON CHILDREN UNDER 2 YEARS OF AGE, OR IF YOU ARE PREGNANT, NURSING OR HAVE SENSITIVR SKIN.

    IF CONDITIONS WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN SEVEN (7) DAYS, OR CLEAR THEN RECUR WITHIN A FEW DAYS, STOP USE AND CONTACT YOUR PHYSICIAN.

  • DIRECTIONS

    APPLY TO THE AFFECTED AREAS NOT MORE THAN THREE (3) TO FOUR (4) TIMES DAILY. RINSE HANDS WITH COOL WATER.

  • OTHER INFORMATION

    STORE IN A COOL, DRY PLACE WITH LID CLOSED TIGHTLY. KEEP AWAY FROM EXCESSIVE HEAT OR OPEN FLAME.

  • INACTIVE INGREDIENTS

    WATER, SDA ALCOHOL 40-B, CARBOMER, ISOPROPYL ALCOHOL, GLYCERINE, ILEX PARAGUARIENSIS LEAF EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF POWDER, CAPSAICIN, FD7C BLUE #1, FD&C YELLOW 35, TRIETHANOLAMINE

  • DANCER'S SELECT PRODUCT LABEL

    NDC 63347-415-01

    DANCER'S SELECT

    PAIN RELIEVING GEL

    Never Miss

    The Chance to Dance

    MENTHOL AND CAMPHOR

    IN A GEL CONTAINING CAPSAICIN

    88.7 mL (3.0 FL OZ)

    MANUFACTURED BY:

     BLAINE LABS, INC.

    11037 LOCKPORT PLACE

    SANTA FE SPRINGS, CA 90670

    QUESTIONS OR COMMENTS?

    CALL (800) 307-8818, M-F

    8:00AM-5:00 PM (PST)

    *MADE IN THE U.S.A.

    24100-P-LBLDSEL    REV20160217

    Blaine Dancers - 415

  • INGREDIENTS AND APPEARANCE
    DANCERS SELECT 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.1 mg  in 88.7 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.18 min  in 88.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63347-415-0188.7 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2016
    2NDC:63347-415-0288.7 mL in 1 JAR; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2016
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture(63347-415)

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