Active Ingredients And Purpose
Active Ingredient(s)
Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Hand Sanitizer
- Manufacturer
- GMA Supplies LLC
- Effective date
- 2021-05-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:40:29
Key Label Information#
Uses
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
in children less than 2 months of age on open skin wounds
Directions And Dosage
Directions
Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Other Label Information
Other information
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
60 mL NDC: 80869-601-02
Label Images#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 80869-601-02 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b2a3-d8a0-e053-dadaa90a6e4e | c2bba84d-e5b8-7b7b-e053-2995a90a08fa |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80869-601-02 | Hand Sanitizer | 60 mL in 1 BOTTLE | GEL | 60 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- Hand Sanitizer
- Hand Sanitizer Soap
- BENZALKONIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80869-601 | 80869-601-02 |
Ingredients#
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
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.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
in children less than 2 months of age on open skin wounds
OTC - WHEN USING SECTION
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Other information
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
60 mL NDC: 80869-601-02