Milagroso Ointment
FDA Label NDC 55758-417

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Milagroso (NDC 55758-417). 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 drug facts, otc - purpose, uses, warnings, do not, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 - Purpose

Active ingredientPurpose

Camphor 10 %.............................................................

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with

  • back aches
  • arthritis
  • strains
  • sprains

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes .

Do Not

  • apply to on wounds or damaged skin
  • bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Other Information

  • store in a cool dry place
  • ​do not use if seal over cap is broken, torn, or missing

Questions Or Comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

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