Sure Protect Hand Sanitizer
FDA Label NDC 50387-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by E-house Korea Holdings International for the product Sure Protect Hand Sanitizer (NDC 50387-002). 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, use, warnings, otc - when using, otc - keep out of reach of children, 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

Alcohol Denat. 70 %v/v

Purpose

Antimicrobial

Use

  • Helps reduce bacteria on the skin.
  • Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire, sparks and sources of ignition. Do not store above 104°F/40°C

Otc - When Using

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water. 
  • Avoid contact with broken skin.

    • Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Spray directly on hands and rub in thoroughly. For children under 6, use
  • adult supervision. Not recommended for infant.

Inactive Ingredients

Water, Glycerin, Butylene Glycol, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Anthemis Nobilis Flower Extract , Phenoxyethanol, Ethylhexylglycerin

Package Label - Principal Display Panel

Label (Label)

Label (Label)

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