Active Ingredient(S)
Ethyl Alcohol 80% v/v. Purpose: Antiseptic
80% Gel Hand Sanitizer
FDA Label NDC 78044-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cbio Brand Distribution International Inc. for the product 80% Gel Hand Sanitizer (NDC 78044-200). 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 active ingredient(s), purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Gel Hand Sanitizer
Use
To help reduce bacteria on skin.
Warnings
For external use only. Flammable. Keep away from source of heat & fire.
Otc - When Using
When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use & ask doctor if irritation occurs or redness develops & persists.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center immediately.
Directions
Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.
Inactive Ingredients
Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.
Section 3: Use (06/2020) Section 8: Directions (06/2020)
Section 3:
To help reduce bacteria on skin. (06/2020)
Section 8:
Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product. (06/2020)
Package Label - Principal Display Panel
60 mL NDC: 78044-200-07
100 mL NDC: 78044-200-01
250 mL NDC: 78044-200-02
500 mL NDC: 78044-200-03
3.785 L NDC: 78044-200-04
208.198 L NDC: 78044-200-05
1003.13 L NDC: 78044-200-06
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