LUXURY HAND SANITIZER ALOE- ethyl alcohol gel

Luxury Hand Sanitizer by

Drug Labeling and Warnings

Luxury Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 70%

Purpose: Antiseptic

Purpose

Antiseptic

Uses

• helps reduce bacteria on the skin
• For use when soap and water are not available

Directions

• Place enough product in your palm to thoroughly cover your hands
• Rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Safety Instructions

Flammable, Keep away from fire and flame

Ask Doctor

Stop Use and Ask a doctor if irritation or redness develops

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

Other Information

Store below 110°F (43°C)
May discolor certain fabrics or surfaces.

Inactive Ingredients

water, glycerin, carbomer, aminomethyl propanol, fragrance, Aloe, Tocopheryl Acetate. Please review Label for further details

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUXURY HAND SANITIZER  ALOE
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76772-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76772-021-47	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
2	NDC: 76772-021-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
3	NDC: 76772-021-23	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
4	NDC: 76772-021-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2020

Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Establishment
Name	Address	ID/FEI	Business Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI		533120570	manufacture(76772-021)