FDA Label for Rfl Antiseptic Hand Sanitizer
View Indications, Usage & Precautions
Rfl Antiseptic Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Rfl Akvaryum Sistemleri Sanayi Ve Ticaret Limited 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) (78,5%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol
- Aloe vera leaf juice
- 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 78,5% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
for hand washing to decrease bacteria on the skin.
Warnings
For external use only. Flammable. Keep away from fire or flame
Do Not Use
- in the eyes.
Otc - When Using
Stop use and ask a doctor if
-irritation and redness develop.
-condition persists for more than 72 hours.
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 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
- Wet hands thoroughly with product and allow to dry without wiping.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
aloe vera leaf juice, deionized water, glycerin.
Package Label - Principal Display Panel
250 mL NDC: 86807-001-01
* Please review the disclaimer below.