LARA MED ANTIBACTERIAL HAND SKIN CLEANER- alcohol-isopropyl alcohol aerosol, spray

LARA MED Antibacterial Hand Skin Cleaner by

Drug Labeling and Warnings

LARA MED Antibacterial Hand Skin Cleaner 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) (60.7%, 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. Isopropyl Alcohol 8.7% (v/v)
3. Glycerol (1.3% (v/v)
4. BUTANE (3.25% (v/v)
5. PROPANE (0.875% (v/v)
6. ISOBUTANE (0.875% (v/v)
7. FD&C Blue No.1 (0.0001% (v/v)
8. 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 60.7% v/v. Purpose: Antiseptic

Isopropyl Alcohol 8.7% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

In order to maintain personel hygiene, it can be easily used in any environment that does not require soap without dilution.

For use when soap and water are not available. Ready to use. For use in examinations and clinics where surgical skin hygiene needed. For use before injection, and surgery and intensive care wherever hand and skin hygiene is required.

Warnings

For external use only. If irritation occurs, discontinue use.

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 the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation, sensitization or allergin reaction 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.

Flammable Do not use while smoking or near heat or flame

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

• use 3 ml product in your palm and hands. Rubbed well for 30 seconds. 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 between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• Keep away sunlight.
• Pressurized container: Do not pierce or burn, even after use.

Inactive ingredients

Butane, Glycerol, Propane, Isobutane, FD&C Blue No.1, Water

Package Label - Principal Display Panel

100 mL NDC: 86994-006-01

86994-006-02 NDC - 150 ml

86994-006-03 NDC - 300 ml

INGREDIENTS AND APPEARANCE

LARA MED ANTIBACTERIAL HAND SKIN CLEANER 
alcohol-isopropyl alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86994-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60.7 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	8.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.3 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0001 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24.2999 mL  in 100 mL
BUTANE (UNII: 6LV4FOR43R)	3.25 mL  in 100 mL
ISOBUTANE (UNII: BXR49TP611)	0.875 mL  in 100 mL
PROPANE (UNII: T75W9911L6)	0.875 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86994-006-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020
2	NDC: 86994-006-02	150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020
3	NDC: 86994-006-03	300 mL in 1 BOTTLE, SPRAY; 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 - 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(86994-006)