Easy
FDA Label NDC 11446-188

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wong�s Pharmaceutical International for the product Easy (NDC 11446-188). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, 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

Active Ingredients

Menthol 4%

Purpose

External Analgesic

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises

Warnings

  • For external use only
  • Avoid getting into the eyes or on mucus membranes.

When Using This Product

  • do not apply to wound or damaged skin.
  • do not bandage tightly
  • do not use otherwise than as directed

Stop Use And Ask A Doctor If

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • pain persists for more than 10 days
  • redness is present
  • conditions affect children under 12 years of age

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Dosage & Administration

Directions
Adults and children2 years of age and older. Apply to affected area not more than 3-4 times daily.

Children under 2 years of age: Do not use, consult a doctor

Inactive Ingredient

Inactive Ingredients Sesame Oil, Terebinthina resin, Zinc Oxide and Methyl salicylate

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Package Label

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