Dosage and administration
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.
Loews Sapphire Falls Hand Sanitizer Gel
- Manufacturer
- Carretta USA, Inc
- Effective date
- 2020-06-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:19:01
Label at a glance#
ProductLoews Sapphire Falls Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure9 sections
Storage and handling
Store between 15-30C (59-83F) Avoid freezing and excessive heat above 40C (104F)
Label contents#
Full prescribing information#
Active Ingredient
Ethyl Alcohol 75% v/v
Purpose
Antiseptic
Use[s]
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
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 right away.
Directions
- 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 information
- Store between 15-30C (59-83F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients:
Water,Glycerin,Propylene glycol,Carbomer,Aloe Vera Extract,Triethanolamine,Disodium Edta
SPL UNCLASSIFIED SECTION
*99.99% of most common germs.
Distributed by:Carretta USA, Inc.
1500 County Road 517, Ste. 210
Hackettstown, NJ 07840
Packaging
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78828-119-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-aa35-a426-e053-dadaa90af4c2 | Loews Sapphire Falls Hand Sanitizer Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78828-119-01 | Loews Sapphire Falls Hand Sanitizer Gel | 30 mL in 1 BOTTLE | GEL | 30 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Loews Sapphire Falls Hand Sanitizer Gel
- Ethyl Alcohol
- ALCOHOL
- WATER
- GLYCERIN
- PROPYLENE GLYCOL
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- ALOE VERA LEAF
- TROLAMINE
- EDETATE DISODIUM ANHYDROUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78828-119 | 78828-119-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| EDETATE DISODIUM ANHYDROUS | 8NLQ36F6MM | 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 |
|---|---|---|---|---|---|---|
| 63cf925f-5298-4e09-a305-b5e3c7a2f1af | 6ae3f13c-b63e-49b6-9484-752ff4d4e23f | 2020-06-13 | Warnings | 63cf925f-5298-4e09-a305-b5e3c7a2f1af 6ae3f13c-b63e-49b6-9484-752ff4d4e23f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.