HANDSANITIZER- alcohol solution

HandSanitizer by

Drug Labeling and Warnings

HandSanitizer by is a Otc medication manufactured, distributed, or labeled by Lords & Ladies Hair Nail & Skin Care, Cospro Development 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) 
2. Sterile distilled water.

Active Ingredient(s)

Alcohol 70%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from fire and flame

Do not use

Do not use in or near eyes

WHEN USING

When using this product do not use in or near eyes. 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

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 briskly until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110F (43C)

Inactive ingredients

Deionized water, glycerin, tocopheryl acetate, isopropyl myristate, aloe barbadensis leaf juice, maltodextrin, citrus aurantium dulcis peel oil, acrylates/C10-30 Alkyl Acrylate Crosspolymer, Amminomethyl Propanol

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HANDSANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77826-112
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
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ORANGE PEEL (UNII: TI9T76XD44)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77826-112-01	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2020

Labeler - Lords & Ladies Hair Nail & Skin Care (114608339)

Registrant - Cospro Development Corp (785638821)

Establishment
Name	Address	ID/FEI	Business Operations
Cospro Development Corp		785638821	manufacture(77826-112) , label(77826-112) , pack(77826-112)