PAIN RELIEVING (MENTHOL, CAMPHOR) GEL [BLAINE LABS INC.]

PAIN RELIEVING (MENTHOL, CAMPHOR) GEL [BLAINE LABS INC.]
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NDC 63347-215-01, 63347-215-02, 63347-215-03
Set ID 0e2aa14e-9c2a-45f5-8fb9-71abac7a655e
Category HUMAN OTC DRUG LABEL
Packager Blaine Labs Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • DRUG FACTSActive Ingredient

    Menthol 3.5%

    Camphor 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 associated 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 mucous membranes. Ask your physician before using on children under two years of age, or if you are pregnant, nursing, or have sensitive skin.

    If condition worsen, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, stop use and contact your physician.

  • Directions

    Apply to the affected areas not more than 3-4 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, llex Paraguariensis Leaf Extract, Camellia Sinensis (Green Tea) Leaf Powder, Glycerine, Capsaicin, FD&C Blue #1, FD&C Yellow #5, Triethanolamine

  • Pain Relieving Gel product label

    NDC: 63347-215-02

    Pain Relieving Gel

    PRACTICE
    EXCLUSIVE

    Menthol 3.5%

    Camphor 0.2%

    Capsaicin 0.01%

    6.0 FL OZ

    Manufactured by:
    Blaine Labs Inc.

    11037 Lockport Place

    Santa Fe Springs, CA 90670

    Blaine PainRel - 215

    res

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 mg  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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:63347-215-0188.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product04/01/2016
    2NDC:63347-215-02177 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2016
    3NDC:63347-215-03946.4 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2016
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture(63347-215)

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