Dosage and administration
Put enough product in your palm to cover hands and rub hands together quickly until dry. Children under 6 years of age should be supervised when using.
LOLES Naturals Hand Sanitizer
- Manufacturer
- Diora Kimya Sanayi ve Ticaret Limited Sirketi | US Naturals Corp
- Effective date
- 2022-01-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:47:49
Label at a glance#
ProductLOLES Naturals Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections
Storage and handling
Store below 110 F (43 C)
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: Antimicrobial
Purpose
Antimicrobial, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria on the skin
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
When using this product do not use in ot near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
OTC - WHEN USING SECTION
When using this product do not use in ot near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
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
- Put enough product in your palm to cover hands and rub hands together quickly until dry.
- Children under 6 years of age should be supervised when using.
Other information
- Store below 110 F (43 C)
Inactive ingredients
Deionized Water, Propylene Glycol, Acrylates Copolymer, Sodium Hyroxide, Fragrance (Parfum), Glycerin, Mentha viridis (Spearmint) Leaf Oil
Package Label - Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
250 mL NDC: 73485-001-02
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73485-001-01 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-f30c-a426-e053-dadaa90af4c2 | a58aa07b-42aa-6c2c-e053-2a95a90af35d |
| 73485-001-02 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-f30c-a426-e053-dadaa90af4c2 | a58aa07b-42aa-6c2c-e053-2a95a90af35d |
| 73485-001-01 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-f30c-a426-e053-dadaa90af4c2 | a58aa07b-42aa-6c2c-e053-2a95a90af35d |
| 73485-001-02 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-f30c-a426-e053-dadaa90af4c2 | a58aa07b-42aa-6c2c-e053-2a95a90af35d |
| 73485-001-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f30c-a426-e053-dadaa90af4c2 | a58aa07b-42aa-6c2c-e053-2a95a90af35d |
| 73485-001-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f30c-a426-e053-dadaa90af4c2 | a58aa07b-42aa-6c2c-e053-2a95a90af35d |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73485-001-01 | LOLES Naturals Hand Sanitizer | 100 mL in 1 BOTTLE, PLASTIC | GEL | 100 | 2 | |
| 73485-001-02 | LOLES Naturals Hand Sanitizer | 250 mL in 1 BOTTLE, PLASTIC | GEL | 250 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- LOLES Naturals Hand Sanitizer
- ALCOHOL
- GLYCERIN
- SODIUM HYDROXIDE
- WATER
- BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73485-001 | 73485-001-02, 73485-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) | JZ1374NL9E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | 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 |
|---|---|---|---|---|---|---|
| d6e4813a-e7f1-18e8-e053-2995a90afed3 | a58aa07b-42aa-6c2c-e053-2a95a90af35d | 2022-01-31 | Warnings | d6e4813a-e7f1-18e8-e053-2995a90afed3 a58aa07b-42aa-6c2c-e053-2a95a90af35d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.