LENCURAPRO by LENCURA DIRECT, INC. 16.9oz

LENCURAPRO by

Drug Labeling and Warnings

LENCURAPRO by is a Otc medication manufactured, distributed, or labeled by LENCURA DIRECT, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LENCURAPRO- alcohol gel 
LENCURA DIRECT, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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16.9oz

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 hands. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• on 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 Center right away.

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 Center right away.

Directions

• Place enough product in your palm to cover hands. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store below 110F (43C)

Inactive ingredients

Water, Glycerin, Hydrogen Peroxide, Polyacrylate Crosspolymer, DEA99

Package Label - Principal Display Panel

500 mL NDC: 77912-002-01

LENCURAPRO 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77912-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
(3-AMINOPROPYL)DIETHANOLAMINE (UNII: R21ZI8N14B)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77912-002-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	09/01/2020

Labeler - LENCURA DIRECT, INC. (117519185)

Revised: 12/2020

Document Id: b7c987ff-e7b9-ea19-e053-2995a90a05ea

34390-5

Set id: a70bd564-d42d-9fa7-e053-2a95a90a4e63

Version: 5

Effective Time: 20201231