LUXURY HAND SANITIZER- ethyl alcohol gel
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Luxury Hygiene Hand Sanitizer: Advanced Regular

Active Ingredients

Ethyl Alcohol 70%

Purpose: Antiseptic

Purpose

Antiseptic

Uses

to 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

LUXURY HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76772-020
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76772-020-47	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
2	NDC:76772-020-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
3	NDC:76772-020-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
4	NDC:76772-020-23	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

Name	Address	ID/FEI	Business Operations
Establishment
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI		533120570	manufacture(76772-020)