LARAMED ANTIBACTERIAL ALCOHOL WIPES- alcohol, isopropanol, benzalkonium chloride cloth

LARAMED Antibacterial Alcohol Wipes by

Drug Labeling and Warnings

LARAMED Antibacterial Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI. 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) (65%, weight/weight (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Isopropanol 10%, (w/w)
3. Benzalkonium Chloride 0.05%, (w/w)
4. Glycerol
5. Tocopherol
6. 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 65% w/w. Purpose: Antiseptic

Isopropanol 10% w/w. Purpose: Antiseptic

Benzalkonium chloride 0.05% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable liquid and vapor.

Do not use

• in children less than 2 months of age
• on open skin wounds

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

• Open package, removeonewetwipetocleanyourhands| and body. Reseal, keep closed to prevent evaporation. Allow to dry without wiping. Discard properly after use.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store below 110F ( 43 C)
• Avoid freezing and excessive heat above 40C (104F)
• May discolor certain fabrics or surface.

Inactive ingredients

Glycerol
Tocopherol

purified water USP

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LARAMED ANTIBACTERIAL ALCOHOL WIPES 
alcohol, isopropanol, benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86994-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 g  in 100 g
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	10 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86994-007-32	1 in 1 PACKAGE	03/30/2020
1	NDC: 86994-007-31	3.244 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 86994-007-30	15 in 1 PACKAGE	03/30/2020
2	NDC: 86994-007-29	48.66 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 86994-007-28	50 in 1 PACKAGE	03/30/2020
3	NDC: 86994-007-27	162.2 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 86994-007-26	70 in 1 PACKAGE	03/30/2020
4	NDC: 86994-007-25	227.08 g in 1 PATCH; Type 0: Not a Combination Product
5	NDC: 86994-007-24	100 in 1 PACKAGE	03/30/2020
5	NDC: 86994-007-23	324.4 g in 1 PATCH; Type 0: Not a Combination Product
6	NDC: 86994-007-22	120 in 1 PACKAGE	03/30/2020
6	NDC: 86994-007-21	389.28 g in 1 PATCH; Type 0: Not a Combination Product
7	NDC: 86994-007-20	150 in 1 PACKAGE	03/30/2020
7	NDC: 86994-007-19	486.6 g in 1 PATCH; Type 0: Not a Combination Product
8	NDC: 86994-007-18	200 in 1 PACKAGE	03/30/2020
8	NDC: 86994-007-17	648.8 g in 1 PATCH; Type 0: Not a Combination Product

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

Labeler - LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI (502977856)

Registrant - LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI (502977856)

Establishment
Name	Address	ID/FEI	Business Operations
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI		502977856	manufacture(86994-007)