Kellys Delight Hand Sanitizer (Pumpkin Pecan Waffles): Package Insert and Label Information

KELLYS DELIGHT HAND SANITIZER (PUMPKIN PECAN WAFFLES)- alcohol gel
WACO BOTTLING LLC

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.

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. 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 20-25C(68-77F)

•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

Kellys Delight Pumpkin Pecan Waffles Hand Sanitizer
(click image for full-size original)

KELLYS DELIGHT HAND SANITIZER (PUMPKIN PECAN WAFFLES)
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79175-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
ISOPROPYL MYRISTATE
POLYETHYLENE GLYCOL 300
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)
ALPHA-TOCOPHEROL ACETATE
ETHYL MALTOL
BENZYL BENZOATE
BENZYL ALCOHOL
CINNAMALDEHYDE
ETHYL VANILLIN
VANILLIN
BUTYL BUTYRYLLACTATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79175-009-01 59 mL in 1 BOTTLE, PLASTIC None
2 NDC:79175-009-02 118 mL in 1 BOTTLE, PLASTIC None
3 NDC:79175-009-03 236 mL in 1 BOTTLE, PLASTIC None
4 NDC:79175-009-04 473 mL in 1 BOTTLE, PLASTIC None
5 NDC:79175-009-05 500 mL in 1 BOTTLE, PLASTIC None
6 NDC:79175-009-06 946 mL in 1 BOTTLE, PLASTIC None
7 NDC:79175-009-07 1000 mL in 1 BOTTLE, PLASTIC None
8 NDC:79175-009-08 1893 mL in 1 BOTTLE, PLASTIC None
9 NDC:79175-009-09 3785 mL in 1 BOTTLE, PLASTIC None
10 NDC:79175-009-10 18927 mL in 1 BOTTLE, PLASTIC None
11 NDC:79175-009-11 208198 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/03/2020
Labeler — WACO BOTTLING LLC (080331158)
Establishment
Name Address ID/FEI Operations
WACO BOTTLING LLC 080331158 manufacture (79175-009)

Revised: 08/2020 WACO BOTTLING LLC

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