LARA MED ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

LARA MED Antibacterial Wet Wipes by

Drug Labeling and Warnings

LARA MED Antibacterial Wet 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. Benzalkonium Chloride (USP or Food Chemical Codex (FCC) grade) (0.15%, weight/weight (w/w)) in an aqueous solution denatured Trade Bureau regulations in 27 CFR part 20
2. ALLANTOIN,
3. ALOE BARBADENSIS LEAF JUICE,
4. BENZOIC ACID,
5. CITRIC ACID,
6. COCAMIDOPROPYL BETAINE,
7. DEHYDROACETIC ACID,
8. DICAPRYLYL CARBONATE,
9. GLYCERIN,
10. GLYCERYL OLEATE,
11. LAURYL GLUCOSIDE,
12. OLUS OIL,
13. PANTHENOL,
14. PARFUM,
15. PHENOXYETHANOL,
16. POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE,
17. POLYSORBATE 20,
18. PROPYLENE GLYCOL,
19. 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)

Benzalkonium Chloride 0.15% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Standard usage Antibacterial wet wipes; soak the closed and impermeable package inside hot water until it gets warm. Microwave usage: Heat the package at 750 W for seconds by lag label side openly.

Antibacterial Wet wipes: Whenever is necessary and needed, it can be used as 1 piece for patients to wipe.It is used to clean who is incontinent position in need bath.

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

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
• if you are allergic to chlorhexidine gluconate or any other ingredients.

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, sensitization or allergic reaction 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, remove one wet wipes to clean your hands 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 at room temparature.
• Do not flush down toilet.

Inactive ingredients

ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, BENZOIC ACID, CITRIC ACID, COCAMIDOPROPYL BETAINE, DEHYDROACETIC ACID, DICAPRYLYL CARBONATE, GLYCERIN, GLYCERYL OLEATE, LAURYL GLUCOSIDE, OLUS OIL, PANTHENOL, PARFUM, PHENOXYETHANOL, POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE, POLYSORBATE 20, PROPYLENE GLYCOL, WATER

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LARA MED ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86994-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DEHYDROACETIC ACID (UNII: 2KAG279R6R)	0.0525 g  in 100 g
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)	0.06 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.0375 g  in 100 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.0225 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z)	0.06 g  in 100 g
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)	0.01 g  in 100 g
BENZOIC ACID (UNII: 8SKN0B0MIM)	0.091 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.135 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.588 g  in 100 g
WATER (UNII: 059QF0KO0R)	97.911 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.225 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.0375 g  in 100 g
GLYCERYL OLEATE (UNII: 4PC054V79P)	0.01 g  in 100 g
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)	0.06 g  in 100 g
DEXPANTHENOL (UNII: 1O6C93RI7Z)	0.15 g  in 100 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	0.15 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86994-004-11	50 in 1 PACKAGE	03/30/2020
1	NDC: 86994-004-10	0.06885 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 86994-004-07	15 in 1 PACKAGE	03/30/2020
2	NDC: 86994-004-06	0.03285 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 86994-004-13	80 in 1 PACKAGE	03/30/2020
3	NDC: 86994-004-12	0.0552 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 86994-004-15	120 in 1 PACKAGE	03/30/2020
4	NDC: 86994-004-14	0.0552 g in 1 PATCH; Type 0: Not a Combination Product
5	NDC: 86994-004-09	24 in 1 PACKAGE	03/30/2020
5	NDC: 86994-004-08	0.0139 g in 1 PATCH; Type 0: Not a Combination Product
6	NDC: 86994-004-17	100 in 1 PACKAGE	03/30/2020
6	NDC: 86994-004-16	0.0552 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(86994-004)