Dosage and administration
Apply enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under age 6 should be supervised when using this product.
Sunmitte Hand Sanitizer
- Manufacturer
- Henan Shizheng Pharmaceutical Technology Co., Ltd.
- Effective date
- 2020-04-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:08:22
Label at a glance#
ProductSunmitte Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections
Storage and handling
Store between 1-30C (33.8-86F) Avoid freezing and excessive heat above 40C (104F)
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 (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerin(3% v/v).
- Carbomer(0.8% v/v).
- Trolamine(0.2% 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)
Isopropyl Alcohol 75% 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
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 and lasts.
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
- Apply enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.
- Children under age 6 should be supervised when using this product.
Other information
- Store between 1-30C (33.8-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
glycerin, carbomer, water, Trolamine
Package Label - Principal Display Panel
59 ml NDC: 75138-120-06
100 ml NDC: 75138-120-10
300 ml NDC: 75138-120-30
500 ml NDC: 75138-120-50
500 ml NDC: 75138-120-51
500 ml NDC: 75138-120-52
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75138-120-06 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f119-a426-e053-dadaa90af4c2 | Sunmitte Hand Sanitizer Product Listing |
| 75138-120-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f119-a426-e053-dadaa90af4c2 | Sunmitte Hand Sanitizer Product Listing |
| 75138-120-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f119-a426-e053-dadaa90af4c2 | Sunmitte Hand Sanitizer Product Listing |
| 75138-120-50 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f119-a426-e053-dadaa90af4c2 | Sunmitte Hand Sanitizer Product Listing |
| 75138-120-51 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f119-a426-e053-dadaa90af4c2 | Sunmitte Hand Sanitizer Product Listing |
| 75138-120-52 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f119-a426-e053-dadaa90af4c2 | Sunmitte Hand Sanitizer Product Listing |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75138-120-06 | Sunmitte Hand Sanitizer | 59 mL in 1 BOTTLE, PLASTIC | GEL | 59 | 1 | |
| 75138-120-10 | Sunmitte Hand Sanitizer | 100 mL in 1 BOTTLE, PLASTIC | GEL | 100 | 1 | |
| 75138-120-30 | Sunmitte Hand Sanitizer | 300 mL in 1 BOTTLE, PUMP | GEL | 300 | 1 | |
| 75138-120-50 | Sunmitte Hand Sanitizer | 500 mL in 1 BOTTLE, PUMP | GEL | 500 | 1 | |
| 75138-120-51 | Sunmitte Hand Sanitizer | 500 mL in 1 BOTTLE, PUMP | GEL | 500 | 1 | |
| 75138-120-52 | Sunmitte Hand Sanitizer | 500 mL in 1 BOTTLE, PUMP | GEL | 500 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sunmitte Hand Sanitizer
- Isopropyl Alcohol
- TROLAMINE
- GLYCERIN
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- WATER
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75138-120 | 75138-120-06, 75138-120-10, 75138-120-30, 75138-120-50, 75138-120-51, 75138-120-52 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TROLAMINE | 9O3K93S3TK | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | 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 |
|---|---|---|---|---|---|---|
| a42dba05-4f0b-ace3-e053-2995a90abdbe | a44fa866-b191-3373-e053-2a95a90a6344 | 2020-04-26 | Warnings | a42dba05-4f0b-ace3-e053-2995a90abdbe a44fa866-b191-3373-e053-2a95a90a6344 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.