OTC - ACTIVE INGREDIENT SECTION
alcohol
alcohol
Water
Glycerin
Carbomer
Triethanolamine
Rosmarinus Officinalis (Rosemary) Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Rose Centifolia Flower Water
Citrus Aurantium Dulcis (Orange) Oil
Limonene
Sterilization of hands and skin
KEEP OUT OF REACH OF THE CHILDREN
Apply an appropriate amount on your hands and rub well to dry.
1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and
ears, in the oral cavity (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms
3. Other precautions
1) For external use only (do not underwear).
2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the
mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).
4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.
5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.
6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.
7) Do not use for any other purpose.
4. Precautions for storage
1) Avoid shading and keep in shading.
2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign
Objects.
for external use only
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 80594-0001-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-61b0-a426-e053-dadaa90af4c2 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80594-0001-1 | Protect By Hand Sanitizer gel (ethanol) | 60 mL in 1 BOTTLE | GEL | 60 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80594-0001 | PROTECT BY HAND SANITIZER GEL (ETHANOL) (ALCOHOL) GEL [KEN COMPANY CO., LTD.] | 1 | Legacy NDC, 1 package rows | 20200915_af51cc6b-eda6-dd90-e053-2995a90a508d.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 80594-0001 | 80594-0001-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIMONENE, (+)- | GFD7C86Q1W | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ROSEMARY OIL | 8LGU7VM393 | IACT |
| MATRICARIA RECUTITA | G0R4UBI2ZZ | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ORANGE OIL | AKN3KSD11B | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
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 |
|---|---|---|---|---|---|---|
| af51c93b-c287-74f7-e053-2a95a90ac8a5 | af51cc6b-eda6-dd90-e053-2995a90a508d | 2020-09-14 | Warnings | af51c93b-c287-74f7-e053-2a95a90ac8a5 af51cc6b-eda6-dd90-e053-2995a90a508d |
Adverse event summaries are temporarily unavailable. Other product information remains available.