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  5. Label Information: Handsanitizeramericanmale

FDA Label for Handsanitizeramericanmale

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. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Handsanitizeramericanmale Product Label

The following document was submitted to the FDA by the labeler of this product Genesis Salon Products 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 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:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade)
  • Glycerol.
  • Hydrogen peroxide.
  • Sterile distilled water.

Active Ingredient(S)



Ethyl Alcohol 70%. Purpose: Antiseptic


Purpose



Antiseptic, Hand Sanitizer


Use



Hand Sanitizer to help reduce bacteria on the skin


Warnings



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


Do Not Use



  • in or around eyes

Otc - When Using



When using this product do not use in or near eyes. If contact occurs, rinse eyes thoroughly with water.


Otc - Stop Use



Stop use and ask a doctor if irritation or rash appears and lasts. 


Otc - Keep Out Of Reach Of Children



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


Directions



  • Put enough product in your palm to cover hands and rub together briskly until dry. 
  • Children under 6 years of age should be supervised when using this product.

Other Information



  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces

Inactive Ingredients



deionized water, glycerin, polysorbate 20, aloe barbadensis leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum


Package Label - Principal Display Panel



image description - Americanmale

image description - Americanmale


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