Careall Arthritis And Muscle Cream
FDA Label NDC 51824-094

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Arthritis And Muscle (NDC 51824-094). 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 ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsaicin  0.025%

Purpose

Topical Analgesic

Keep Out Of Reach Of Children

Keep out of Reach of Children.  If swallowed, get medical helpor contact a Posion Control Center immediately.

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backaches, strains, and sprains

Warnings

Warnings.For external use only.  Read all warnings and directions before use.  Tet first on small area of skin.

Do not use

  • On wounds or damaged skin
  • If you are allergic to capsicum or chili peppers

    • When using this product

    • You may experience a burning sensation.  The intensity of this reaction varies among individuals and may be severe.  With regular use, this sensation generally disappears after several days
    • Avoid contact with the eyes, lips, nose or mucous membranes.  If this occurs, rinse the affected area thoroughly with water
    • Do no apply immediately before or after activites such as bathing, swimming, sunbathing, or strenuous exercise
    • Do not tightly wrap or bandage the treated area
    • Do no apply heat to the treated area immediately before or after use
    • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin
    • Avoid inhaling airborne material from dried residue.  This can result in coughing, sneezing, tearing, or throat/respiratory irritation

      • 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
      • Severe burning persists, or blistering occurs
      • Difficulty breathing or swallowing occurs

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

Directions

Directions

Adults and children 18 years of age and older:

  • Apply a thin film of cream to affected area and gently rub in until fully absorbed
  • Unless treating hands, wash hand thoroughly with soap and water immediately after application
  • For best results, apply 3 to 4 times daily

    • Children 18 years of age and younger: ask a doctor

Inactive Ingredients

Benzyl Alcohol, Cetyl Alcohol, Citric Acid, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Purified Water, Sorbitol

* Please review the disclaimer below.