Dosage and administration
Place enough product in palm to thoroughly cover your hands. Rub together briskly until dry. Supervise children when using this product to avoid swallowing.
Hand Sanitizer
- Manufacturer
- Foggy Mountain Spirit Company
- Effective date
- 2020-05-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:13:33
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections
Storage and handling
Store between 15-30C (59-86F)
Label contents#
Full prescribing information#
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.
375 sani back FDA.jpg
375 sani front FDA.jpg
750 sani back FDA.jpg
750 sani front FDA.jpg
Active Ingredient(s)
Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Antiseptic Refill
Warnings
External use only. Do Not Ingest. Flammable. Keep away from flame. Keep Out Of Reach of Children. Do Not Use In or Near The Eyes. If Conatct Occurs Flush With Water.
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.
Directions
- Place enough product in palm to thoroughly cover your hands. Rub together briskly until dry.
- Supervise children when using this product to avoid swallowing.
Other information
- Store between 15-30C (59-86F)
Inactive ingredients
glycerin, hydrogen peroxide, purified water, BITREX (denaturant)
Package Label - Principal Display Panel
750 mL NDC: 74914-001-02
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 74914-001-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b667-a426-e053-dadaa90af4c2 | a330d224-1863-f6d3-e053-2a95a90a9ec9 |
| 74914-001-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b667-a426-e053-dadaa90af4c2 | a330d224-1863-f6d3-e053-2a95a90a9ec9 |
| 74914-001-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b667-a426-e053-dadaa90af4c2 | a330d224-1863-f6d3-e053-2a95a90a9ec9 |
| 74914-001-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b667-a426-e053-dadaa90af4c2 | a330d224-1863-f6d3-e053-2a95a90a9ec9 |
| 74914-001-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b667-a426-e053-dadaa90af4c2 | a330d224-1863-f6d3-e053-2a95a90a9ec9 |
| 74914-001-06 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b667-a426-e053-dadaa90af4c2 | a330d224-1863-f6d3-e053-2a95a90a9ec9 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 74914-001-01 | Hand Sanitizer | 375 mL in 1 BOTTLE, GLASS | LIQUID | 375 | 3 | |
| 74914-001-02 | Hand Sanitizer | 750 mL in 1 BOTTLE, GLASS | LIQUID | 750 | 3 | |
| 74914-001-03 | Hand Sanitizer | 3785 mL in 1 BOTTLE, PLASTIC | LIQUID | 3785 | 3 | |
| 74914-001-04 | Hand Sanitizer | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 3 | |
| 74914-001-05 | Hand Sanitizer | 118 mL in 1 BOTTLE, GLASS | LIQUID | 118 | 3 | |
| 74914-001-06 | Hand Sanitizer | 236 mL in 1 BOTTLE, PLASTIC | LIQUID | 236 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- ALCOHOL
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 74914-001 | 74914-001-01, 74914-001-02, 74914-001-03, 74914-001-04, 74914-001-05, 74914-001-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a5f362ee-d866-3ef8-e053-2a95a90ab3fc | a330d224-1863-f6d3-e053-2a95a90a9ec9 | 2020-05-18 | Warnings | a5f362ee-d866-3ef8-e053-2a95a90ab3fc a330d224-1863-f6d3-e053-2a95a90a9ec9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.