WHITE FLOWER STRAIN RELIEF (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [JELMA PHILIPPINES INC]

WHITE FLOWER STRAIN RELIEF (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [JELMA PHILIPPINES INC]
PDF | XML

NDC 51681-0041-1, 51681-0041-2, 51681-0041-3
Set ID c0d347eb-eab0-4132-874b-0d162b3fe12c
Category HUMAN OTC DRUG LABEL
Packager JELMA PHILIPPINES INC
Generic Name
Product Class
Product Number
Application Number PART348
  • 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:
    ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

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

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if
    ■ condition worsens
    ■ symptoms persist for more than 7 days
    ■ symptoms clear up and occur again within a few days
    ■ excessive irritation develops
    ■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    ■ when using for pain of arthritis:
        ■ pain persists for more than 10 days
        ■ redness is present
        ■ 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
    ■ 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.
    ■ children under 3 years of age: do not use, consult your physician
    ■ refer to the above warnings; use otherwise than as directed may be dangerous

  • STORAGE AND HANDLING

    Other information
    ■ store at 15º to 30º C (59º to 86º F)
    ■ 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:51681-0041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE50 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51681-0041-150 mL in 1 BOTTLE, GLASS
    2NDC:51681-0041-225 mL in 1 BOTTLE, GLASS
    3NDC:51681-0041-33 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/20/2012
    Labeler - JELMA PHILIPPINES INC (721085447)
    Establishment
    NameAddressID/FEIBusiness Operations
    JELMA PHILIPPINES INC721085447repack
    Establishment
    NameAddressID/FEIBusiness Operations
    HOE HIN PAK FAH YEOW MANUFACTORY LTD686359001manufacture

Related Drugs