LUSTI THERAPEUTIC ICE ANALGESIC RUB (MENTHOL, CAMPHOR) GEL [JF LABS, INC.]

LUSTI THERAPEUTIC ICE ANALGESIC RUB (MENTHOL, CAMPHOR) GEL [JF LABS, INC.]
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NDC 49681-010-10
Set ID 9511fceb-09ca-d7ce-f222-5676c563e4d2
Category HUMAN OTC DRUG LABEL
Packager New Life Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • OTC - ACTIVE INGREDIENT SECTION

    Menthol 1.5%                                                 Camphor 3.1%                                                               

  • OTC - PURPOSE SECTION

    Topical Analgesic. Temporarily relieves the minor aches and paiins associated with simple backache, arthritis, sprains, strains and bruises.

  • Use:

    Temporarily relieves the minor aches and pains associated with simple backache, arthritis, sprains, and bruises.

  • WARNINGS SECTION

    For external use only

  • OTC - DO NOT USE SECTION

    Do not use on wounds or damaged skin.  Do not use with a heating pad.  Do not use on a child under 12 years of age with arthritis-like conditions.

  • OTC - ASK DOCTOR SECTION

    Ask a doctor before use if you have redness over the affected area.

  • OTC - WHEN USING SECTION

    Avoid contact with eyes or mucous membranes. If contact occurs, rinse thoroughly with water.

  • OTC - STOP USE SECTION

    Stop use of this product and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again or excessive skin irritation occurs.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS SECTION

    Apply liberally to painful area and massage until gel is absorbed into the skin.  Repeat three to four times daily.

  • INACTIVE INGREDIENT SECTION

    Inactive ingredients:  Water (Aqua), Propylene Glycol, Mineral Oil, Carbomer, Triethanolamine, Methylparaben, Propylparaben, DMDM Hydantoin, Blue 1

  • OTC - QUESTIONS SECTION

    Questions or comments: www.jflabs.comJF LABS, INC. Chicago, Illinois 60629

  • PACKAGE LABEL.

    Package Label

    BONUS SIZE

    Lusti

    PROFESSIONAL

    Therapeutic ICE

    Analgesic Rub

    NET WT. 10 OZ. e 284g

    Deep Penetrating

    Greaseless Pain Relief

    Fast relief from minor

    arthritis, backache, muscle,

    and joint pain

  • INGREDIENTS AND APPEARANCE
    LUSTI THERAPEUTIC ICE ANALGESIC RUB  
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM.015 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC).031 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49681-010-10284 g in 1 JAR; Type 0: Not a Combination Product03/24/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/24/2010
    Labeler - New Life Products, Inc. (117815140)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Life Products, Inc.117815140MANUFACTURE(49681-010)

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