Xtracare Hand Sanitizer
FDA Label NDC 58503-044

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by China Ningbo Shangge Cosmetic Technology Corp for the product Xtracare Hand Sanitizer (NDC 58503-044). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                                       Purpose

Ethyl Alcohol 62.0% ................................ Antimicrobial

Otc - Purpose

Uses

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use

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.

Indications & Usage

XtraCare® Hand Sanitizer Antibacterial

Kills 99.9% of Germs

Moisturize with Vitamin E & Aloe

8 Fl Oz (236 mL)

Warnings

Warnings

For external use only.

Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

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

Dosage & Administration

Directions

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children under 6 years in the use of this product

Inactive Ingredient

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate, fd&c blue no. 1, fd&c yellow no.5

Other Safety Information

Other information

  • store at 20oC to 25oC (68o to 77oF)
  • may discolor certain fabrics

    • Questions/Comments? 1-855-345-5575

    DISTRIBUTED BY: 

    REJOICE INTERNATIONAL, INC

    NORTHVILLE, MI 48168. USA

    MADE IN CHINA

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