FDA Label for Lara Med Antibacterial Wet Wipes
View Indications, Usage & Precautions
Lara Med Antibacterial Wet Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Lara Kozmetik Hijyenik Urunleri Sanayi Ve Dis Ticaret Anonim Sirketi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- Chlorhexidine gluconate (USP or Food Chemical Codex (FCC) grade) (0.127%, weight/weight (w/w)) in an aqueous solution denatured Trade Bureau regulations in 27 CFR part 20
- 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
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)
Chlorhexidine gluconate 0.127% w/w. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Standard usage Antibacterial Perinia region wet towel; 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 Pernia region
Washing towel: 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.
Otc - 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.
Otc - Stop Use
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.
Otc - 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
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