Scar Zone Burn Topical Analgesic And Antiseptic
FDA Label NDC 61543-6174

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cca Industries, Inc. for the product Scar Zone Burn Topical Analgesic And Antiseptic (NDC 61543-6174). 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, use, warnings, keep out of reach of children, do not use in the eyes or over an area larger than the palm of your hand, stop use and ask a doctor if increased redness or weeping or pain persist or clears up and occurs again within a few days, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

LIDOCAINE 2.00%
BENZALKONIUM CHLORIDE 0.13%

Purpose

TOPICAL ANALGESIC/ANESTHETIC
FIRST AID ANTISEPTIC

Use

  • For temporary relief of pain or discomfort, for first degree burns or superficial second degree burns and to help prevent infection in: minor burns, cuts, scrapes.

Warnings

  • Seek medical attention immediately if burn is severe
  • For external use only
  • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

Keep Out Of Reach Of Children

Do Not Use In The Eyes Or Over An Area Larger Than The Palm Of Your Hand

  • Do not use longer than 1 week unless directed by a doctor

Stop Use And Ask A Doctor If Increased Redness Or Weeping Or Pain Persist Or Clears Up And Occurs Again Within A Few Days

Directions

Adults and children 2 years and over

  • Clean the affected area
  • Lightly apply to the affected area 1 to 3 times daily
  • May be covered with a sterile bandage

    • Children under 2 years, consult a doctor.

Inactive Ingredients

ALLANTOIN, ALLIUM CEPA (ONION) BULB EXTRACT, ALOE BARBADENSIS LEAF JUICE, BENZYL ALCOHOL, BUTYLENE GLYCOL, CALOPHYLLUM TACAMAHACA (TAMANU) SEED OIL, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, CITRIC ACID, GLYCERIN, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, METHYLISOTHIAZOLINONE, PHENOXYETHANOL, PHYTONADIONE, POLYSORBATE 60, PROPYLENE GLYCOL, SODIUM POLYACRYLATE, WATER (AQUA).

Questions Or Comments?

  • Call 1-800-595-6230 Report any issues associated with this product to the telephone number or address listed on this package.

Scar Zone Burn Gel Topical Analgesic & Antiseptic 0.5Oz/14G (61543-6174)


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