LARAMED ANTIBACTERIAL HAND SANITIZER GEL- ethyl alcohol, propan-2-ol gel

LARAMED Antibacterial Hand Sanitizer Gel by

Drug Labeling and Warnings

LARAMED Antibacterial Hand Sanitizer Gel 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) (70%, volume/volume (w/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Propan-2-ol (10% w/v).
3. Glycerin
4. Aloe vera extract
5. Carbomer
6. Triethanolamine
7. 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 (ethanol)(70%, volume/volume (w/v))
Propan-2-ol (10% w/v).

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 the 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

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

Other information

• Store between 110F (43 C )
• Avoid freezing and excessive heat above 40C (104F)
• May discolor certain fabrics or surface.
• Ethyl Alcohol % 70
• Porpan-2-ol %10
• Non sterile topical solution

Inactive ingredients

Glycerin
Aloe vera extract
Carbomer
Triethanolamine
water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LARAMED ANTIBACTERIAL HAND SANITIZER GEL 
ethyl alcohol, propan-2-ol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86994-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	10 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86994-008-01	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 86994-008-02	10000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
3	NDC: 86994-008-03	50000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
4	NDC: 86994-008-04	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
5	NDC: 86994-008-13	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
6	NDC: 86994-008-06	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
7	NDC: 86994-008-07	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
8	NDC: 86994-008-08	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
9	NDC: 86994-008-09	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
10	NDC: 86994-008-15	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
11	NDC: 86994-008-16	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
12	NDC: 86994-008-17	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
13	NDC: 86994-008-18	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
14	NDC: 86994-008-19	800 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 - 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(86994-008)