Dosage and administration
wet hands thoroughly with product brisky rub hands together until dry supervise children under 6 years in the use of this product
Hand Sanitizer
- Manufacturer
- THINH PHAT - KOREA SX TM XNK PHARMACEUTICAL COSMETICS COMPANY
- Effective date
- 2020-10-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:31:38
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure14 sections
Storage and handling
Store at the normal temperatur may discolor certain fabrics
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.
Active Ingredient(s)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
for handwashing to decrease bacteria on the skin
recommended for repeated use
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
- in the 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
- wet hands thoroughly with product
- brisky rub hands together until dry
- supervise children under 6 years in the use of this product
Other information
- Store at the normal temperatur
- may discolor certain fabrics
Inactive ingredients
aqua, propylene glycol, fragrance apple, carbomer, triethanolamine, glycerin
RECENT MAJOR CHANGES SECTION
Uses: rewording of uses.
Direction: rewording of direction.
Package Label - Principal Display Panel
70ml NDC: 78819-100-01
100ml NDC: 78819-100-02
250ml NDC: 78819-100-03
500ml NDC: 78819-100-04
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78819-100-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6341-a426-e053-dadaa90af4c2 | a7a58f82-b517-4798-e053-2a95a90ace51 |
| 78819-100-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6341-a426-e053-dadaa90af4c2 | a7a58f82-b517-4798-e053-2a95a90ace51 |
| 78819-100-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6341-a426-e053-dadaa90af4c2 | a7a58f82-b517-4798-e053-2a95a90ace51 |
| 78819-100-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6341-a426-e053-dadaa90af4c2 | a7a58f82-b517-4798-e053-2a95a90ace51 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78819-100-01 | Hand Sanitizer | 70 mL in 1 BOTTLE | GEL | 70 | 3 | |
| 78819-100-02 | Hand Sanitizer | 100 mL in 1 BOTTLE | GEL | 100 | 3 | |
| 78819-100-03 | Hand Sanitizer | 250 mL in 1 BOTTLE | GEL | 250 | 3 | |
| 78819-100-04 | Hand Sanitizer | 500 mL in 1 BOTTLE | GEL | 500 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- ALCOHOL
- APPLE
- GLYCERIN
- CARBOMER 940
- TROLAMINE
- PROPYLENE GLYCOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78819-100 | 78819-100-01, 78819-100-02, 78819-100-03, 78819-100-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| APPLE | B423VGH5S9 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| b1b26cba-dd36-82f4-e053-2a95a90a50dd | a7a58f82-b517-4798-e053-2a95a90ace51 | 2020-10-15 | Warnings | b1b26cba-dd36-82f4-e053-2a95a90a50dd a7a58f82-b517-4798-e053-2a95a90ace51 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.