Ism Be-you-tiful Self Care Studio
FDA Label NDC 80797-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Horizon Group Usa, Inc. for the product Ism Be-you-tiful Self Care Studio (NDC 80797-001). 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 ingredients, purpose, warnings, uses, directions, keep out of reach of children., other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Ethyl Alcohol

Purpose

Antiseptic

Warnings

  • For external use only. Flammable. Keep away from heat or flame.
  • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
  • Do not use in children less than 2 months of age; on open skin wounds
  • When using this product keep out of eyes, ears, and mouth.
  • In case of contact with eyes, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Uses

  • Hand Sanitizer to help reduce bacteria that potentially can cause disease.
  • For use when soap and water are not available.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Keep Out Of Reach Of Children.

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

Other Information

Store between 15-30C (59-86F); Avoid freezing or excessive heat above 40C (104F)

Inactive Ingredient

Water/Aqua/Eau,Glycerin,Carbomer,Triethanolamine,parfum,Denatonium benzoate,Red 27 (CI 45410).

Product Label

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