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  5. Label Information: All Hands Co. Hand Sanitizer

FDA Label for All Hands Co. Hand Sanitizer

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT(S)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT USE
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTC - QUESTIONS
    14. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

All Hands Co. Hand Sanitizer Product Label

The following document was submitted to the FDA by the labeler of this product Specified Coating Technologies Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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

The hand sanitizer 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:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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)



Alcohol 80% v/v. Purpose: Antiseptic


Purpose



Antiseptic, Hand Sanitizer


Use



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


Do Not Use



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

Other Information



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

* Please review the disclaimer below.