Dosage and administration
Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Hand Sanitizer
- Manufacturer
- Kepter Mexico S.A de C.V
- Effective date
- 2020-06-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 23:18:46
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections
Storage and handling
Store below 110F (43C) Avoid freezing. May discolor certain fabrics/surfaces.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:
a. Alcohol (ethanol) (USP of 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.
b. Glycerin (.5% v/v).
c. Carbopol (.5% v/v).
d. Triethanolamine (.4% v/v).
e. Sterile distilled water or boiled cold water.
Active Ingredient(s)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Antiseptic Hand Sanitizer to reduce germs on the skin. For use when soap and water not available.
Warnings
For external use only. Flammable. Keep away from open flame and sources of heat.
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 doctor: If irritation, rash or redness ocurrs. These may be signs of a serious condition.
Keep out reach of children: If swallowed, get medical help or contat a Posion Control Center right away.
OTC - STOP USE SECTION
Stop use and ask doctor: If irritation, rash or redness 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 Posion Control Center right away.
Directions
Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Other information
Store below 110F (43C)
Avoid freezing. May discolor certain fabrics/surfaces.
Inactive Ingredients
Water, Glycerin, Carbopol, Triethanolamine
Package Label - Principal Display Panel
976 ml NDC: 78391-001-01
3786 ml NDC: 78391-001-02
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78391-001-01 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-22f2-fd44-e053-dadaa90aa01b | Hand Sanitizer |
| 78391-001-02 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-22f2-fd44-e053-dadaa90aa01b | Hand Sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78391-001-01 | Hand Sanitizer | 976 mL in 1 BOTTLE | GEL | 976 | 5 | |
| 78391-001-02 | Hand Sanitizer | 3786 mL in 1 BOTTLE | GEL | 3786 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- Alcohol
- WATER
- GLYCERIN
- TROLAMINE
- CARBOMER 940
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78391-001 | 78391-001-01, 78391-001-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| CARBOMER 940 | 4Q93RCW27E | 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 |
|---|---|---|---|---|---|---|
| a8c8b491-55ef-22e0-e053-2995a90ac5f2 | a6e158dc-731e-7c32-e053-2a95a90a65b7 | 2020-06-23 | Warnings | a8c8b491-55ef-22e0-e053-2995a90ac5f2 a6e158dc-731e-7c32-e053-2a95a90a65b7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.