Pomada Dragon Pain Relieving Cream
FDA Label NDC 55038-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Televisa Consumer Products Usa for the product Pomada Dragon Pain Relieving (NDC 55038-001). 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, warnings, otc - do not use, otc - ask doctor, 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                                                                             Purpose

Camphor 4%.................................................................................Topical analgesic

Menthol 10%.................................................................................Topical analgesic

Methyl Salicylate 30%.....................................................................Topical analgesic

Otc - Purpose

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12years of age with arthritis-like conditions

Otc - Ask Doctor

Ask a doctor before use

if you have redness over the affected area

Otc - When Using

When using this product

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

Otc - Stop Use

Stop use and ask a doctor if

  • conditions worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Directions

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Storage And Handling

Other information

  • Store between 20o and 25o C (68o and 77oF)

Inactive Ingredient

Inactive ingredients: DEA-cetyl phosphate, glycerin, isopropyl myristate, methylparaben, polysorbate 60, propylparaben, purified lanolin, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum

Dosage & Administration

Distributed By:

Televisa Consumer Products USA, LLC

4550 Post Oak Place Suite 325

Houston, TX 77027

Made in Korea

* Please review the disclaimer below.