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.
Pro-Sanitize
- Manufacturer
- Clean Beauty Concepts
- Effective date
- 2020-05-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:11:29
Label at a glance#
ProductPro-Sanitize
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
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
- Acrylates/C10 30 Alkyl acrylate crosspolymer(.20% v/v)
- Aminomethyl propanol (.085% v/v)
- Fragrance (Parfum) (.50% v/v)
Active Ingredient(s)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic
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
water(aqua), glycerin, acrylates/C10 30 alkyl acrylate crosspolymer, aminomethyl propanol, hydrogen peroxide, fragrance(parfum).
Package Label - Principal Display Panel
473 mL NDC: 76665-002-16
60 mL NDC: 76665-002-02
170 mL NDC: 76665-002-06
236 mL NDC: 76665-002-08
3785 ML NDC: 76665-002-01
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 |
|---|---|---|---|---|---|
| 76665-002-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a664-a426-e053-dadaa90af4c2 | a44fa866-b18e-3373-e053-2a95a90a6344 |
| 76665-002-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a664-a426-e053-dadaa90af4c2 | a44fa866-b18e-3373-e053-2a95a90a6344 |
| 76665-002-06 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a664-a426-e053-dadaa90af4c2 | a44fa866-b18e-3373-e053-2a95a90a6344 |
| 76665-002-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a664-a426-e053-dadaa90af4c2 | a44fa866-b18e-3373-e053-2a95a90a6344 |
| 76665-002-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a664-a426-e053-dadaa90af4c2 | a44fa866-b18e-3373-e053-2a95a90a6344 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76665-002-01 | Pro-Sanitize | 3785 mL in 1 BOTTLE, DISPENSING | LIQUID | 3785 | 2 | |
| 76665-002-02 | Pro-Sanitize | 60 mL in 1 BOTTLE, DISPENSING | LIQUID | 60 | 2 | |
| 76665-002-06 | Pro-Sanitize | 178 mL in 1 BOTTLE, DISPENSING | LIQUID | 178 | 2 | |
| 76665-002-08 | Pro-Sanitize | 236 mL in 1 BOTTLE, DISPENSING | LIQUID | 236 | 2 | |
| 76665-002-16 | Pro-Sanitize | 473 mL in 1 BOTTLE, DISPENSING | LIQUID | 473 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Pro-Sanitize
- Hand Sanitizer
- CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
- EUCALYPTUS OIL
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
- ALCOHOL
- AMINOMETHYLPROPANOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76665-002 | 76665-002-06, 76665-002-02, 76665-002-08, 76665-002-01, 76665-002-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) | 59TL3WG5CO | IACT |
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| AMINOMETHYLPROPANOL | LU49E6626Q | 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 |
|---|---|---|---|---|---|---|
| a5a3a26f-fa46-272d-e053-2a95a90a1685 | a44fa866-b18e-3373-e053-2a95a90a6344 | 2020-05-14 | Warnings | a5a3a26f-fa46-272d-e053-2a95a90a1685 a44fa866-b18e-3373-e053-2a95a90a6344 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.