Safly Burn Cream
FDA Label NDC 43473-039

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nantong Health & Beyond Hygienic Products Inc. for the product Safly Burn (NDC 43473-039). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCI         0.5%

Otc - Purpose

Purpose

First Aid Antiseptic
Topical Analgesic

Indications & Usage

Uses

Temporary relief of pain associated with minor cuts, scrapes, and burns.
Helps protect against harmful bacteria.

Warnings

Warnings

For external use only.

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions 

  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage

Storage And Handling

Other Information

  • store at room temperature
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredient

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate/PÉG-100 Stearate, Maltodextrin, Mineral Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine.

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Image Description (Label)

Image Description (Label)

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