Satsuma
FDA Label NDC 57691-564

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Body Shop Wake Forest for the product Satsuma (NDC 57691-564). 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 other, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - 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

Other

Drug Facts

Active Ingredients

Alcohol 73.4%

Purpose

Antiseptic hand wash

Uses

  • Hand washing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

  • Flammable, keep away from fire or flame.
  • For external use only.

Otc - When Using

When using this product

  • Do not use in the eyes.
  • Do not use on broken skin.

Otc - Stop Use

  • Stop use and ask a doctor if irritation and redness develop or condition persists 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 right away. Children under 6 should be supervised when using this product.

Directions

  • Wet hands thoroughly with product and allow to dry without wiping.

Inactive Ingredients

Water, Betaine, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-40 Hydrogenated Castor Oil, Aminomethyl Propanol, Limonene, Fragrance, t-Butyl Alcohol, Hexyl Cinnamal, Citrus Unshiu Fruit Extract, Citral, Citrus Aurantium Dulcis (Orange) Oil, Disodium EDTA, Anthemis Nobilis Flower Extract, Linalool, Citrus Unshiu Fruit Oil, Denatonium Benzoate.

Principal Display Panel - 60 Ml Bottle Label

THE
BODY
SHOP®

SATSUMA
ANTIBACTERIAL
HAND SANITIZER
Kills 99.9% of germs. NO TRICLOSAN

60 mL (2.0 US FL OZ)

Principal Display Panel (60 mL Bottle Label)

Principal Display Panel (60 mL Bottle Label)

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