RFL ANTISEPTIC HAND SANITIZER- alcohol liquid

RFL Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

RFL Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by RFL AKVARYUM SISTEMLERI SANAYI VE TICARET LIMITED 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) (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.
2. Glycerol
3. Aloe vera leaf juice
4. 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.

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.

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

• 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

INGREDIENTS AND APPEARANCE

RFL ANTISEPTIC HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86807-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	78.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86807-001-01	250 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 - RFL AKVARYUM SISTEMLERI SANAYI VE TICARET LIMITED SIRKETI (505257103)

Registrant - RFL AKVARYUM SISTEMLERI SANAYI VE TICARET LIMITED SIRKETI (505257103)

Establishment
Name	Address	ID/FEI	Business Operations
RFL AKVARYUM SISTEMLERI SANAYI VE TICARET LIMITED SIRKETI		505257103	manufacture(86807-001)