Fast Relief Reumacetin
FDA Label NDC 69706-0204

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Interfarma Corp for the product Fast Relief Reumacetin (NDC 69706-0204). 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, uses, warnings:, otc - keep out of reach of children, dosage & administration, directions, inactive ingredients:, manufactured for:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient:                             Purpose:

Menthol 2.5%...................................External Analgesic

Methyl Salicylate 15%......................External Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Warnings:

  • For external use only.
  • Do not use this product if safety seal is broken. Store in room temperature.
  • Do not use on wounds or damaged skin. Do not apply in large quantities, particularly on raw and irritated or blistered areas.
  • When using this product, avoid contact with eyes or mucus membranes. Use only as directed. Do not bandage tightly.
  • Stop and ask doctor if condition worsen, if symptoms persist within 7 days or clear up and occur again within a few days. Stop use if excessive skin irritation occurs.
  • If pregnant or breast feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning.

Dosage & Administration

Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or mucous membranes. If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

Directions

Apply to the affected area. Gently massage into the skin for a few seconds. Adults and children over 12 years of age: apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age need to consult a physician.

Inactive Ingredients:

Acrymalide, Amino Acids, Comfrey Leaf, Cetyl Alcohol, Diazolidinyl Urea, Dimethicone, Glucosamine, Methyl Paraben, MSM (Methylsulfonylmethane), Mineral Oil, Panthenol, Propylene Glycol, Propylparaben, Sodium Pyrrolidone Carboxylate, Stearic Acid, Stearyl Alcohol, Trolamine, Water.

Manufactured For:

Interfarma Corp.

Miami, FL 33186.

Fast Reliefreumacetin

For Temporarily Relieves minor aches and pains soreness, and stiffness associated with simple backaches strains, arthritis and rheumatism.

Net Wt 8 oz (226g)

Made in USA

Image Description (Reumacetin)

Image Description (Reumacetin)

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