KELLYS DELIGHT HAND SANITIZER- alcohol gel

Kellys Delight Hand Sanitizer by

Drug Labeling and Warnings

Kellys Delight Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by WACO BOTTLING LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from heat or flame

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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.
• Briskly rub hands together until dry.
• Supervise children in the use of this product.

Other information

• Store at 20-250C(68-770F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Fragrance (Parfum), Glycerin, lsopropyl Myristate, PEG-6 & AMP Acrylates I Vinyl lsodecanoate Crosspolymer, Tocopheryl Acetate.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

KELLYS DELIGHT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79175-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)
LINALYL ACETATE (UNII: 5K47SSQ51G)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
BERGAMOT OIL (UNII: 39W1PKE3JI)
3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79175-003-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
2	NDC: 79175-003-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
3	NDC: 79175-003-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
4	NDC: 79175-003-04	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
5	NDC: 79175-003-05	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
6	NDC: 79175-003-06	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
7	NDC: 79175-003-07	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
8	NDC: 79175-003-08	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
9	NDC: 79175-003-09	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
10	NDC: 79175-003-10	18927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
11	NDC: 79175-003-11	208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/08/2020

Labeler - WACO BOTTLING LLC (080331158)

Establishment
Name	Address	ID/FEI	Business Operations
WACO BOTTLING LLC		080331158	manufacture(79175-003)