Label: WHITE FLOWER STRAIN RELIEF- camphor, menthol and methyl salicylate oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 20, 2012

If you are a consumer or patient please visit this version.

  • 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