Dosage and administration
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.
Hand Sanitizer
- Manufacturer
- SanitizeNow Inc.
- Effective date
- 2020-10-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:31:46
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections
Storage and handling
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:
Alcohol (ethanol) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Sterile distilled water or boiled cold water.
Hydrogen Peroxide
Glycerin
Isopropyl Myristate 0% to < 0.25%
Propylene Glycol
Carbomer and/or acrylates/alkyl polymers
Aloe Arborescens Leaf
Tocopheryl Acetate
Fragrance
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 70% 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
- in eyes. In case of contact, rinse eyes thoroughly with water
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
Water, Hydrogen Peroxide, Glycerin, Carbomer and/or Crosspolymers, Isopropyl Myristate 0% to < 0.25%, Propylene Glycol, Aloe Arborescens Leaf and/or Tocopheryl Acetate, Fragrance.
Package Label - Principal Display Panel
355 mL NDC: 74988-731-35
59 mL NDC: 74988-731-20
118 mL NDC: 74988-731-40
236 mL NDC: 74988-731-80
473 mL NDC: 74988-731-16
3.79 L NDC: 74988-731-37
208 L NDC: 74988-731-55
1041 L NDC: 74988-731-41
25741 L NDC: 74988-731-74
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 74988-731-16 | Hand Sanitizer | 473 mL in 1 BOTTLE | GEL | 473 | 4 | |
| 74988-731-20 | Hand Sanitizer | 59 mL in 1 BOTTLE | GEL | 59 | 4 | |
| 74988-731-35 | Hand Sanitizer | 355 mL in 1 BOTTLE | GEL | 355 | 4 | |
| 74988-731-37 | Hand Sanitizer | 3790 mL in 1 JUG | GEL | 3790 | 4 | |
| 74988-731-40 | Hand Sanitizer | 118 mL in 1 BOTTLE | GEL | 118 | 4 | |
| 74988-731-41 | Hand Sanitizer | 1041000 mL in 1 TANK | GEL | 1041000 | 4 | |
| 74988-731-55 | Hand Sanitizer | 208000 mL in 1 DRUM | GEL | 208000 | 4 | |
| 74988-731-74 | Hand Sanitizer | 25741000 mL in 1 CONTAINER | GEL | 25741000 | 4 | |
| 74988-731-80 | Hand Sanitizer | 236 mL in 1 BOTTLE | GEL | 236 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- ALCOHOL
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- PROPYLENE GLYCOL
- .ALPHA.-TOCOPHEROL ACETATE, D-
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
- ISOPROPYL MYRISTATE
- ALOE ARBORESCENS LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 74988-731 | 74988-731-20, 74988-731-40, 74988-731-80, 74988-731-16, 74988-731-37, 74988-731-55, 74988-731-41, 74988-731-74, 74988-731-35 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| .ALPHA.-TOCOPHEROL ACETATE, D- | A7E6112E4N | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| ALOE ARBORESCENS LEAF | 09TD8L5SQV | IACT |
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 |
|---|---|---|---|---|---|---|
| b1d0f168-6e59-7f32-e053-2a95a90a7a36 | a820cdea-2972-3f10-e053-2a95a90afa4b | 2020-10-16 | Warnings | b1d0f168-6e59-7f32-e053-2a95a90a7a36 a820cdea-2972-3f10-e053-2a95a90afa4b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.