Debachere Butt Balm After Care Antiseptic Pain Relief Cream
FDA Label NDC 84847-540

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by De.bachere Usa Llc for the product Debachere Butt Balm After Care Antiseptic Pain Relief (NDC 84847-540). 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:, do not use, when using this product, stop use and ask a doctor if, 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

Benzocaine 5.00%

Benzalkonium Chloride 0.10%

Purpose

Topical Analgesic

Antiseptic

Uses:

  • For the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
  • First aid help prevent infection in minor cuts, scrapes, and burns.

Warnings:

For external use only,not intended for ingestion.

Do Not Use

  • in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

When Using This Product

  • avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • The condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

  • Clean the affected area.
  • Adults and children 2 years of age and older. Apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other Information:

Store at 20-25°C (60-77°F) and protect from moisture.

Inactive Ingridients:

Aloe extract, Beeswax, Camphor, Cetyl Esters, Ethyl vanillin, Helianthus (sunflower) Oil, Lanolin, Menthol, Paraffin Wax, Salicylic Acid, Theobroma Cacao (cocoa) butter, FD&C Blue # 1.

Package Labeling:

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