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  5. Label Information: White Flower Analgesic Balm Floral Scented

FDA Label for White Flower Analgesic Balm Floral Scented

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 Floral Scented 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 5.4%

Menthol 13.1%

Methyl salicylate 36%


Otc - Purpose



Purpose

External analgesic


Otc - Do Not Use



Do not use

  • on irritated or damaged skin
  • on wounds
  • 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 one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
  • children under 3 years of age and pregnant women: do not use, consult a physician
  • refer to the above warnings; use otherwise than as directed may be dangerous

Storage And Handling



Other information

  • keep tightly sealed
  • store at or below 30° C (86° F), away from direct sunlight

Inactive Ingredient



Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.


Otc - Questions



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

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

Package Label.Principal Display Panel



WHITE FLOWER ANALGESIC BALM FLORAL SCENTED  NDC-48256-0011-1  0.338 fl oz (10 mL)

IMAGE OF CARTON 10ML - Box

IMAGE OF CARTON 10ML - Box


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.