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  5. Label Information: White Flower Analgesic Balm

FDA Label for White Flower Analgesic Balm

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - DO NOT USE
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. OTC - QUESTIONS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    12. INDICATIONS & USAGE
    13. WARNINGS

White Flower Analgesic Balm Product Label

The following document was submitted to the FDA by the labeler of this product Hoe Hin Pak Fah Yeow Manufactory Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients

Camphor 6%

Menthol 15%

Methyl salicylate 40%


Otc - Purpose



Purpose

External analgesic



Otc - Do Not Use




Do not use

  • on wounds
  • on irritated or damaged skin
  • on the face
  • otherwise than as directed

Otc - When Using



When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

Otc - 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 of the skin 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

Otc - 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 a few drops then gently rub into the affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Do not use, consult your doctor.
  • Refer to the above warnings; use otherwise than as directed may be dangerous.

Storage And Handling



Other information

  • keep container tightly closed
  • store at 15° to 30°C (59° to 86°F)

Inactive Ingredient



Inactive ingredients

Eucalyptus oil, lavender oil and peppermint oil.


Otc - Questions



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

  • you may also report serious side effects to this phone number

Package Label.Principal Display Panel



WHITE FLOWER ANALGESIC BALM  NDC-48256-0002-1  0.67 fl oz (20mL)


Indications & Usage



Uses  For the temporary relief of minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



Warnings

For external use only


* Please review the disclaimer below.