FDA Label for Lara Med Antibacterial Hand Skin Cleaner
View Indications, Usage & Precautions
Lara Med Antibacterial Hand Skin Cleaner 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:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (60.7%, weight/weight (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Isopropyl Alcohol 8.7% (w/w)
- Glycerol (1.3% (w/w)
- BUTANE (3.25% (w/w)
- PROPANE (0.875% (w/w)
- ISOBUTANE (0.875% (w/w)
- FD&C Blue No.1 (0.0001% (w/w)
- 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
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, 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
Otc - Stop Use
Stop use and ask a doctor if irritation or rash 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
- 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:86994-003-01
86994-003-02 NDC - 150 ml
86994-003-03 NDC - 300 ml
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