White Flower Analgesic Balm Oil
FDA Label NDC 48256-0002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hoe Hin Pak Fah Yeow Manufactory Ltd for the product White Flower Analgesic Balm (NDC 48256-0002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.