LOLES NATURALS HAND SANITIZER- alcohol gel

LOLES Naturals Hand Sanitizer by

Drug Labeling and Warnings

LOLES Naturals Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Diora Kimya Sanayi ve Ticaret Limited Sirketi, US Naturals Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

1. 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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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.

WHEN USING

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.

STOP USE

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

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

Registrant - US Naturals Corp (081035629)

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