White Flower Analgesic Balm Floral Scented Oil
FDA Label NDC 48256-0011

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 Floral Scented (NDC 48256-0011). 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 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.