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NDC 73485-0001-01 LOLES Naturals Hand Sanitizer 70 mL/100mL Details

LOLES Naturals Hand Sanitizer 70 mL/100mL

LOLES Naturals Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Diora Kimya Sanayi ve Ticaret Limited Sirketi. The primary component is ALCOHOL.

Product Information

NDC	73485-0001
Product ID	73485-001_d6e4813a-e7f1-18e8-e053-2995a90afed3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	LOLES Naturals Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Diora Kimya Sanayi ve Ticaret Limited Sirketi
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73485-0001-01 (73485000101)

Pricing Information	N/A
NDC Package Code	73485-001-01
Billing NDC	73485000101
Package	100 mL in 1 BOTTLE, PLASTIC (73485-001-01)
Marketing Start Date	2020-03-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a58aa07b-42aa-6c2c-e053-2a95a90af35d Details

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.

SPL UNCLASSIFIED 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.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

SPL UNCLASSIFIED 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

100 mL NDC: 73485-001-01

PRINCIPAL DISPLAY PANEL

250 mL NDC: 73485-001-02

INGREDIENTS AND APPEARANCE

LOLES NATURALS HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73485-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.5 mL in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.2 mL in 100 mL
WATER (UNII: 059QF0KO0R)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)	5.75 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73485-001-02	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC:73485-001-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Diora Kimya Sanayi ve Ticaret Limited Sirketi (533104358)

Registrant - US Naturals Corp (081035629)

Name	Address	ID/FEI	Business Operations
Establishment
Diora Kimya Sanayi ve Ticaret Limited Sirketi		533104358	manufacture(73485-001)

Revised: 1/2022

Document Id: d6e4813a-e7f1-18e8-e053-2995a90afed3

Set id: a58aa07b-42aa-6c2c-e053-2a95a90af35d

Version: 2

Effective Time: 20220131

Search by Drug Name or NDC

NDC 73485-0001-01 LOLES Naturals Hand Sanitizer 70 mL/100mL Details

LOLES Naturals Hand Sanitizer 70 mL/100mL

Product Information

Package

Package Images

NDC 73485-0001-01 (73485000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a58aa07b-42aa-6c2c-e053-2a95a90af35d Details

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

Purpose

Use

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Package Label - Principal Display Panel

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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