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WHITE FLOWER STRAIN RELIEF (JELMA PHILIPPINES INC)

Available Formats

Dosage Form Package Information Links
OIL 25 mL in 1 BOTTLE, GLASS (51681-0041-2) Label Information
OIL 50 mL in 1 BOTTLE, GLASS (51681-0041-1) Label Information
OIL 3 mL in 1 BOTTLE, GLASS (51681-0041-3) Label Information

Complete WHITE FLOWER STRAIN RELIEF Information

  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 10%
    Menthol 15%
    Methyl Salicylate 50%


  • PURPOSE

    Purpose
    External Analgesic


  • INDICATIONS & USAGE

    Uses
    Tempoarily relieves minor aches and pains of muscles and joints due to:
    â–  simple backache â–  arthritis â–  strains â–  bruises â–  sprains


  • WARNINGS

    Warnings
    For external use only


  • DO NOT USE

    Do not use
    â–  on wounds
    â–  on irritated or damaged skin
    â–  otherwise than as directed


  • WHEN USING

    When using this product
    â–  avoid contact with the eyes or mucous membranes
    â–  do not bandage tightly


  • STOP USE

    Stop use and ask a doctor if
    â–  condition worsens
    â–  symptoms persist for more than 7 days
    â–  symptoms clear up and occur again within a few days
    â–  excessive irritation develops
    â–  nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    â–  when using for pain of arthritis:
        â–  pain persists for more than 10 days
        â–  redness is present
        â–  in conditions affecting children under 12 years of age


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning.
    If swallowed, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions
    â–  adults and children 3 years of age and older: apply on the affected area not more than 3 to 4 times daily.
    After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage gently.
    â–  children under 3 years of age: do not use, consult your physician
    â–  refer to the above warnings; use otherwise than as directed may be dangerous


  • STORAGE AND HANDLING

    Other information
    â–  store at 15º to 30º C (59º to 86º F)
    â–  keep container tightly closed


  • INACTIVE INGREDIENT

    Inactive ingredients
    Beta carotene, Cassia oil, D C Green No. 6, D C Red No. 17, Eucalyptus oil, Fragrance, Lavender oil, Mineral oil.


  • QUESTIONS

    Questions or comments?
    (888) 221-3496 M-F 9 am to 5 pm


  • PRINCIPAL DISPLAY PANEL

    WHITE FLOWER STRAIN RELIEF PAIN RELIEVING OIL  NDC 48256-0041-1  1.7 FL OZ (50 ML)IMAGE OF CARTON 50ML


  • INGREDIENTS AND APPEARANCE
    WHITE FLOWER STRAIN RELIEF 
    camphor, menthol and methyl salicylate oil
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51681-0041
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 50 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BETA CAROTENE (UNII: 01YAE03M7J)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51681-0041-1 50 mL in 1 BOTTLE, GLASS
    2 NDC:51681-0041-2 25 mL in 1 BOTTLE, GLASS
    3 NDC:51681-0041-3 3 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/20/2012
    Labeler - JELMA PHILIPPINES INC (721085447)
    Establishment
    Name Address ID/FEI Business Operations
    JELMA PHILIPPINES INC 721085447 repack
    Establishment
    Name Address ID/FEI Business Operations
    HOE HIN PAK FAH YEOW MANUFACTORY LTD 686359001 manufacture