Active Ingredients And Purpose
Active Ingredient(s)
Alcohol 73% w/w. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Hand Sanitizer
- Manufacturer
- Big Bang Services, L.L.C
- Effective date
- 2020-05-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:11:16
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
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENT SECTION
purified water USP, hydroxypropyl cellulose, glycerin, myristyl lactate, cetyl lactate, lauryl lactate, denatonium benzoate(bitterant/denaturant)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
5 ml NDC:75184-003-01 59 ml NDC:75184-003-02 118 ml NDC:75184-003-04 237 ml NDC:75184-003-08 3785 ml NDC:75184-003-10
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75184-003-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a6cb-a426-e053-dadaa90af4c2 | a56bd182-9482-080e-e053-2995a90aecc2 |
| 75184-003-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a6cb-a426-e053-dadaa90af4c2 | a56bd182-9482-080e-e053-2995a90aecc2 |
| 75184-003-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a6cb-a426-e053-dadaa90af4c2 | a56bd182-9482-080e-e053-2995a90aecc2 |
| 75184-003-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a6cb-a426-e053-dadaa90af4c2 | a56bd182-9482-080e-e053-2995a90aecc2 |
| 75184-003-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a6cb-a426-e053-dadaa90af4c2 | a56bd182-9482-080e-e053-2995a90aecc2 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75184-003-01 | Hand Sanitizer | 5 mL in 1 BOTTLE, SPRAY | SOLUTION | 5 | 1 | |
| 75184-003-02 | Hand Sanitizer | 59 mL in 1 BOTTLE, DISPENSING | SOLUTION | 59 | 1 | |
| 75184-003-04 | Hand Sanitizer | 118 mL in 1 BOTTLE, DISPENSING | SOLUTION | 118 | 1 | |
| 75184-003-08 | Hand Sanitizer | 237 mL in 1 BOTTLE, DISPENSING | SOLUTION | 237 | 1 | |
| 75184-003-10 | Hand Sanitizer | 3785 mL in 1 BOTTLE | SOLUTION | 3785 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- Hand Sanitizer
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75184-003 | 75184-003-01, 75184-003-02, 75184-003-08, 75184-003-10, 75184-003-04 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| CETYL LACTATE | A7EVH2RK4O | IACT |
| MYRISTYL LACTATE | 1D822OC34X | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROXYPROPYL CELLULOSE (90000 WAMW) | UKE75GEA7F | IACT |
| LAURYL LACTATE | G5SU0BFK7O | IACT |
| WATER | 059QF0KO0R | IACT |
| DENATONIUM BENZOATE | 4YK5Z54AT2 | IACT |
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
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). 1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (73%, volume/volume (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. 2. Glycerol (1.5% w/w). 3. Hydroxypropylcellulose(Kulcel H) (1.1% w/w). 4. Ceraphyl 31 ester (1.0% w/w) a. Lauryl Alcohol b. Myristyl Alcohol c. Cetyl Alcohol 5. Denatonium benzoate 6. Sterile distilled water or boiled cold water.
Active Ingredient(s)
Alcohol 73% w/w. 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 Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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.
STORAGE AND HANDLING SECTION
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENT SECTION
purified water USP, hydroxypropyl cellulose, glycerin, myristyl lactate, cetyl lactate, lauryl lactate, denatonium benzoate(bitterant/denaturant)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
5 ml NDC:75184-003-01 59 ml NDC:75184-003-02 118 ml NDC:75184-003-04 237 ml NDC:75184-003-08 3785 ml NDC:75184-003-10