Royal Hh Alcohol Hand Sanitizer
FDA Label NDC 77755-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Code Red Four Limited for the product Royal Hh Alcohol Hand Sanitizer (NDC 77755-001). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand rub is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

    • The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

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Purpose

Antiseptic

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Use

Hand sanitizer to help reduce bateria that can potentially cause disease. For use when soap and water are not available.

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Warnings

For external use only. Flammable. Keep away from heat or flame

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Do Not Use

  • in children less than 2 months of age
  • on open skin wounds

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Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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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.

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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.

Other Information

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

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Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

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Package Label - Principal Display Panel

4 fl oz (120 mL) NDC: 77755-001-01

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