Calmadol Liniment
FDA Label NDC 48201-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Grandall Distributing, Llc for the product Calmadol (NDC 48201-004). 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 other, active ingredients:, purpose:, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients:

Camphor 6.00%

Menthol 1.90%

Methyl Salicylate 10.00%

Purpose:

External Analgesic

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

When Using This Product

  • Avoid contact with eyes and mucous membranes
  • Do not bandage tightly

Stop Use And Ask A Doctor If

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center immediately.

Do Not Use

  • on wounds
  • on damaged skin
  • with heating pad
  • on children under 12 years of age

Directions

  • Use only as directed.
  • Adults and chrldren older than 12 years of age, apply cream to the affected area not more than 3 to 4 trmes daily.
  • For children less than 12 years of age: ask a doctor

Inactive Ingredients

Puified Water (Aqua), Stearic Acid, Glyceryl Stearate, Turpentine, Mentha Piperita (Pepperment) Oil, TEA-Lauryl Sulfate, Triethanolamine, Methylparaben, Propylparaben.

Package Labeling

ARTHRITIS

CALMADOL

NET WT. 6 oz (170.1G)

Ointmentlabel (Ointmentlabel)

Ointmentlabel (Ointmentlabel)

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