FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Cosmetic Specialty Labs, Inc.. 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) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Aloe Barbadenis Leaf Juice.
- Caprylyl Glycol.
- Glycerin.
- Phenoxyethanol.
- Polysorate-20.
- Purified Water.
- Tocopheryl Acetate.
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
SD Alcohol 40 75%
Otc - Purpose
Antimicrobial
Use
Hand Sanitizer to help reduce bacteria on the skin.
subsection identifying number is Sequence 4.
change incorporated in the label on 4/2021.
Warnings
Flammable. Keep away from fire or flame. For external use only.
Otc - When Using
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughtly 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 out of reach of children. If swallowed, get medical help or contact a Poison Center right away.
Directions
- Use enough product in your palm to cover hands and rub hands together biskly until dry.
- Children under 6 years of age should be supervised when using this product.
Identifying number of subsection is 9.
change incorporated in the label 04/2021.
Other Information
- Store below 110F (43C)
- May discolor fabrics or surfaces
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Fragrance, Glycerin, Phenoxyethanol, Polysorbate-20, Purified Water, Tocopheryl Acetate.
Package Label - Principal Display Panel
15 mL NDC:58133-959-16
* Please review the disclaimer below.