White Flower Strain Relief Oil
FDA Label NDC 48256-0041

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 Strain Relief (NDC 48256-0041). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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 10%

Menthol 15%

Methyl salicylate 48%

Otc - 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

Otc - Do Not Use

Do not use

  • on wounds
  • on irritated or damaged skin
  • 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 persis 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

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 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 30° C (86° F) or below, away from direct sunlight.
  • 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.

Otc - Questions

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm

Package Label.Principal Display Panel

WHITE FLOWER STRAIN RELIEF PAIN RELIEVING OIL NDC 48256-0041-1 1.7 FL OZ (50 ML)

Image Of Carton 50ml (Box2)

Image Of Carton 50ml (Box2)

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