Waterless Anti Bacterial Hand Sanitizer
FDA Label NDC 49852-034

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tri-coastal Design Company Inc. for the product Waterless Anti Bacterial Hand Sanitizer (NDC 49852-034). 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, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethyl Alcohol 63%

Purpose

Antiseptic

Uses

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

  • For external use only
  • Flammable, keep away from fire and flame
  • Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances

When Using This Product

  • avoid the eyes an mucous membranes
  • in the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop Use And Ask A Doctor If

  • condition worsens
  • redness or irritation develops
  • if condition persists for more than 3 days

Keep Out Of Reach Of Children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

  • Rub quarter sized amount between hands until dry
  • Supervise children in the use of this product

Other Information

  • Store below 105F
  • May discolor some fabrics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, DC Red 33, FDC Blue 1, Fragrance, Propylene Glycol, Triethanolamine, Water

Package Label

Package Label

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