Theraplus Antibacterial Wipes Fresh Scent With Aloe And Vitamin E Cloth
FDA Label NDC 80684-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Theraplus Antibacterial Wipes Fresh Scent With Aloe And Vitamin E (NDC 80684-007). 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, active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Benzalkonium chloride 0.1%

Purpose

Antibacterial

Use

decreases bacteria on skin

Warnings

For external use only.

Do Not Use

  • over large areas of the body
  • if you are allergic to any of the ingredients

When Using This Product

avoid contact with eyes. If contact occurs, flush thoroughly with water.

Stop Use And Ask A Doctor If

irritation or rash develops and continues for more than 72 hours.

Keep Out Of Reach Of Children.

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

Directions

  • for adults and children of 2 years and over
  • children under 2 year ask a doctor before use
  • allow to dry without wiping

Other Information

store at room temperature

Inactive Ingredients

Water, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barbadensis Leaf Extract, Polyaminopropyl Biguanide, Disodium EDTA, Fragrance, 2-Bromo-2-Nitropropane-1,3-Diol, Tocopheryl Acetate

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

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